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DTSTART;TZID=America/Los_Angeles:20251022T080000
DTEND;TZID=America/Los_Angeles:20251023T170000
DTSTAMP:20251016T161220Z
CREATED:20250818T024556Z
LAST-MODIFIED:20251016T161220Z
UID:13800-1761120000-1761238800@osma.net
SUMMARY:OSMA 2025 Fall Meeting
DESCRIPTION:IMPORTANT UPDATE: It is with sincere regret that we must inform you that the OSMA 2025 Fall Meeting (October 22-23\, 2025) has been cancelled due to the ongoing federal government shutdown. \nWhy This Decision Was Necessary: \nThis unexpected situation has created circumstances beyond our control\, as we have just received this new communication from the FDA: \n\nThe FDA has informed us they cannot host Day 2 at the FDA White Oak Campus due to the shutdown\nFDA speakers are now unable to participate\nA significant portion of our program content relies on FDA participation and expertise\n\nGiven that FDA involvement is central to the educational value of this meeting\, the OSMA Board of Directors has made the difficult decision to cancel rather than proceed with a substantially altered program. \n**Please read all EventBrite Communications and communications from secretary@osma.net as any additional information will first be sent via these channels and may be filtered to your junk folder.** \nThe OSMA Board of Directors thanks you for your understanding and continued support during this challenging time. We remain committed to serving the orthopedic device community and look forward to gathering together in spring 2026. \nFor additional information\, please log into the member website. \n********************************************************************************************** \nJoin us for the OSMA Fall Meeting at the Bethesda North Marriott Hotel and Conference Center on Wednesday\, October 22 and the FDA White Oak Campus on Thursday\, October 23! \nRegistration: Please sign into your OSMA account to view registration link.  If you need to create an OSMA account\, please follow these tutorials: Member Account\, Strategic Partner Account\, Fellows Account \nHotel Block: Rooms have been reserved at the Bethesda North Marriott Hotel and Conference Center for $289 per night plus taxes\, fees.  Hotel block ends September 29\, 2025.  Limited number of rooms available.  Please sign into your OSMA account to view registration link. \nFDA Entrance Requirements: Please note the type of ID required to enter the FDA facility on October 23\, 2025.  Foreign nationals must have the required paperwork submitted by October 14\, 2025.  If you do not have the appropriate ID or you have not filed the appropriate form\, you will not be able to enter the FDA building.  Please sign into your OSMA account to view FDA Entrance Requirements documents. \nTransportation to/from FDA will be arranged (charter bus) based on registration numbers. If you require special accommodations or will be taking private transportation\, feel free to contact mpc@osma.net. \nAgenda Overview:  \n\n\n\n\n\n\n\n\n\n\n\nWEDNESDAY\, OCTOBER 22- Bethesda North Marriott Hotel and Conference Center \nWe will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on: \n\nCapitol Hill Updates\nISO/ASTM Updates\nInnovation in Clinical Study Design\nReimbursement Strategies\nClinical Data in 510k’s\nHuman Factors\n\n  \n\n\n\n\n\n\n\n\n\n\n\nTHURSDAY\, OCTOBER 23- FDA White Oak Campus \nOn the second day of the meeting\, we will leave the Bethesda North Marriott as a group and travel to the FDA White Oak Great Room. Here we will join with FDA employees to discuss topics such as: \n\nOHT-6 Updates\nBuilding a Sustainable Quality Culture in FDA-Regulated Industries\nDHT-6 Updates\nAdditive Manufacturing\nTAP Program Updates\nEvidentiary Expectations for 510k Devices\nUse of AI in CDRH/Industry\nBiocompatibility (Updates and Panel Discussion with Key Industry and FDA Speakers)\n\n  \n\n\n\n\n \nFull agenda coming soon!
URL:https://osma.net/event/osma-2025-fall-meeting-2/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20251022T080000
DTEND;TZID=America/Los_Angeles:20251023T170000
DTSTAMP:20260202T184054Z
CREATED:20250811T220711Z
LAST-MODIFIED:20260202T184054Z
UID:13768-1761120000-1761238800@osma.net
SUMMARY:OSMA 2025 Fall Meeting
DESCRIPTION:IMPORTANT UPDATE: It is with sincere regret that we must inform you that the OSMA 2025 Fall Meeting (October 22-23\, 2025) has been cancelled due to the ongoing federal government shutdown. \nWhy This Decision Was Necessary: \nThis unexpected situation has created circumstances beyond our control\, as we have just received this new communication from the FDA: \n\nThe FDA has informed us they cannot host Day 2 at the FDA White Oak Campus due to the shutdown\nFDA speakers are now unable to participate\nA significant portion of our program content relies on FDA participation and expertise\n\nGiven that FDA involvement is central to the educational value of this meeting\, the OSMA Board of Directors has made the difficult decision to cancel rather than proceed with a substantially altered program. \nYour Registration & Refund: \nAll EventBrite registrations will be cancelled by OSMA\, and you will receive a full refund. You do not need to take any action. Refunds will be processed automatically within 7-10 business days and will appear in your original payment method. \n**Please read all EventBrite Communications and communications from secretary@osma.net as any additional information will first be sent via these channels and may be filtered to your junk folder.** \nHotel Reservation Update: \nThe Bethesda North Marriott has officially cancelled the hotel block. \n\nIf you booked your room through the hotel block link\, you do not need to take any further action. Your reservation has been cancelled.\nIf you booked your room outside of the hotel block\, you will need to cancel your reservation.\n\nVirtual Business Meeting in Q4 2025: \nWhile we cannot proceed with the full Fall Meeting\, OSMA will host a virtual business meeting in Q4 2025 to address critical organizational matters\, including: \n\nBoard seat elections – Voting for open board positions will proceed as scheduled\nOfficer reports and updates\nEssential business matters requiring member action\n\nDetails regarding the date\, time\, and virtual meeting platform will be communicated separately to all OSMA members. The meeting will be open to all members\, but only OSMA voting members will be eligible to participate in the board seat vote. \nLooking Ahead: \nThe FDA has expressed strong interest in postponing the educational sessions to spring 2026 when normal government operations resume. We are committed to rescheduling and will communicate details about a Spring Meeting as soon as they are available. Your registration and payment of fees for this cancelled event will not be carried forward automatically\, but we hope you will join us when we reconvene. \nOur Sincere Apologies: \nThis cancellation comes at a tremendous cost to OSMA\, both financially and in terms of the missed opportunity to bring our community together. However\, we believe this is the right decision given the circumstances. We share your disappointment and frustration with this unprecedented situation. \nThe OSMA Board of Directors thanks you for your understanding and continued support during this challenging time. We remain committed to serving the orthopedic device community and look forward to gathering together in spring 2026. \nIf you have questions or concerns\, please contact us at mpc@osma.net \nSincerely\, \nRyan Belaney\nPresident\, OSMA\nOn behalf of the OSMA Board of Directors \n  \n********************************************************************************************* \n  \nJoin us for the OSMA Fall Meeting at the Bethesda North Marriott Hotel and Conference Center on Wednesday\, October 22 and the FDA White Oak Campus on Thursday\, October 23! \nRegistration: EventBrite Registration \nHotel Block: Although the hotel block has ended\, rooms are still available at the Bethesda North Marriott Hotel and Conference Center. \nAgenda:  The Full Agenda for the Fall Meeting is now available.  Please send speaker questions to mpc@osma.net.  Please see below for additional session information. \nTransportation: Transportation to/from FDA will be arranged (charter bus) based on registration numbers. If you require special accommodations or will be taking private transportation\, please contact mpc@osma.net.  Additional parking and visitor information can be found below. \nFDA Entrance Requirements: Please note the type of ID required to enter the FDA facility on October 23\, 2025.  Foreign nationals must have the required paperwork submitted by October 14\, 2025.  If you do not have the appropriate ID or you have not filed the appropriate form\, you will not be able to enter the FDA building. \n\n\n\nUS citizens and Lawful Permanent Residents\n\n\nNo form or prior approval is required to enter the Great Room.\nThe Visitor must present a VALID (REAL ID compliant) government issued PHOTO identification.\nAn FDA staff will be assigned to escort every 10 U.S. Citizen visitors (1:10).\nConfirm the visitor(s) displays their visitor badge at all times.\nVisitors MUST be under observation and escorted at ALL times. Discovery of unescorted visitor(s) can result in administrative action.\n\n\n\n\nLawful Permanent Resident (LPR) aka “Green Card Holder” of the United States\n\n\nNo form or prior approval is required to enter the Great Room.\nLPR Visitors must show their valid LPR card to enter (no photocopies). No other form of is accepted for LPRs.\nFollow guidance listed above\, as described for U.S. Citizens.\n\n\n\n\nForeign National (FN) Visitors: A Visitor Request Form is required. \n \n\n\nFilled (typed) Foreign National Visitor Data Request Form\, due to OHT6 no later than the close of business on October 14\, 2025.\n\nFDA Foreign National Visitor Data Request Formmay be directly submitted to ester.hatton@fda.hhs.gov\nForms should be sent no earlier than September 23\, 2025\n\nDo not submit more than 30 calendar days in advance.\n\n\nPlease contact jamie.macdougall@outlook.com with any questions\n\n\nA passport is the ONLY accepted form of identification for FN visitors. Inform each visitor to bring their passport.\nVisitors without the EXACT passport provided on the Visit Request Form WILL BE DENIED ENTRY. No exceptions.\nAn FDA staff will escort every 5 FN visitors (1:5).\nPUBLIC AREAS ONLY. No employee offices or labs.\nConfirm the visitor(s) displays their visitor badge at all times.\nVisitors MUST be under observation and escorted at ALL times. Discovery of unescorted visitor(s) can result in administrative action.\n\n\n\n\n\nFDA Parking and Visitor Information: \nThe FDA has advised OSMA members to follow all the instructions here https://www.fda.gov/about-fda/visitor-information \n    Entrance and Parking \n\nIf you click on the Visitor Parking and Campus Map (https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map)\, there’s a section showing where attendees will enter using the Michelson Road entrance for a vehicle screening.  Visitor parking is right off that entrance.  You can park in Northwest Surface Lots 1\, 3\, and 4.\n\n    Shuttle and Screening \n\nThere’s a parking lot shuttle (https://www.fda.gov/about-fda/getting-fda/fda-shuttle-bus) that you can take to Building 1.  This is where the OSMA charter bus will drop everyone off\, and everyone will proceed through security screening to the Great Room (Building 31).\n\n  \nAgenda Overview:  \n\n\n\n\n\n\n\n\n\n\n\n  \nWEDNESDAY\, OCTOBER 22- Bethesda North Marriott Hotel and Conference Center \nWe will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on: \n\nNavigating FDA Submissions in a Changing Environment: Janice Hogan\, Hogan Lovells\n\nThe changing environment and reduced staffing and resources present new challenges for FDA submissions.  This presentation will address how these changes are impacting FDA submission reviews.  Strategies for optimizing FDA interactions in a resource-constrained environment will be discussed\, with recommendations for best practices.\n\n\nYour Standards Snapshot: What’s New and Key Insights in ASTM and ISO Standards: Jason Steffens\, Endolab\, and Leah Guenther\n\nThis session offers an overview of recent updates and upcoming changes to standards developed by the ASTM Subcommittee on Arthroplasty (F04.22) and the ISO Committee on Implants for Surgery – Bone and Joint Replacements (TC 150 SC4).\n\n\nInnovation in Clinical Study Design: Nick Giokas\, MCRA\nReimbursement Strategies: John D. McDermott\, Jr.\, MBA\, MCRA\nClinical Data in 510k’s: Michael Coladonato\, MCRA\nUnboxing Orthopedics: Why Packaging Can Make or Break Safety: Christina Mendat\, PhD\, Eurofins\n\nIn this session\, Christina will share case studies illustrating how packaging design can make or break not only a product but also trust and safety in the operating room. Attendees will learn why packaging is not just a container\, but a critical part of the user interface that must be designed\, tested\, and evaluated with the same rigor as the device itself.\n\n\n\n  \n\n\n\n\n\n\n\n\n\n\n\n  \nTHURSDAY\, OCTOBER 23- FDA White Oak Campus \nOn the second day of the meeting\, we will leave the Bethesda North Marriott as a group and travel to the FDA White Oak Great Room. Here we will join with FDA employees to discuss topics such as: \n\nOffice of Orthopedic Devices (OHT6) Opening Remarks: RDML Raquel Peat\, PhD\, MPH\, FDA\nQuality Culture: Keisha Thomas MS\, MHS\, CQA\, RAC\, FDA\nBuilding a Sustainable Quality Culture in FDA-Regulated Industries: Amra Racic\, Veeva Systems\n\nQuality Culture is a pervasive topic in FDA-regulated industries\, frequently discussed on professional platforms and at conferences. This session will explore how sustainable quality outcomes are achieved through established methodologies and consistent execution. We’ll delve into the concept of Quality System maturity as a key indicator of business process consistency and reliability. Crucially\, we’ll examine the pivotal role of leadership in shaping quality culture\, emphasizing how a leader’s values and beliefs about quality\, communicated both verbally and non-verbally\, directly influence the entire organization.\n\n\nDHT 6A Update: Jiping Chen M.D.\, Ph.D.\, FDA\nDHT 6B Update: Ronald Jean Ph.D.\, FDA\nDHT 6C Update: Laurence Coyne\, Ph.D.\, FDA\nAdditive Manufacturing: David Hwang\, Ph.D. and Jay Kadakia\, M.S.*\, FDA\nTAP Program Updates: Cynthia Chang\, FDA\nCorrosion Testing for Orthopedic Devices: Stephanie Smith\, Ph.D.*\, FDA\nUse of AI in CDRH: S. Raymond Golish\, M.D.\, Ph.D.\, MBA\, FDA\nQuantifying an Art: Industry Use of Data & AI to Improve Spine Surgery: Andrew Fields\, Medtronic\nBiocompatibility Updates: Aprajita Garg\, Ph.D. and Berk Oktem Ph.D.\, FDA\nWhen Change is the Only Constant: Updates to ISO 10993-1 and Other Hot Topics in Biocompatibility: Lindsey Borton\, Gradient Corp\nBiocompatibility Panel Discussion:\n\nModerator- Ron Brown\, Risk Science Consortium\, LLC\nPanelists- Lindsey Borton\, Gradient Corp\, Aprajita Garg\, Ph.D.\, Paul Turner\, Ph.D.\, Carole Wolfe\, Ph.D.\, Berk Oktem\, Ph.D.\, FDA\n\n\n\n  \n\n\n\n\n \n 
URL:https://osma.net/event/osma-2025-fall-meeting/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/08/Copy-of-Corporate-Registration-is-Open-1.png
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250729T080000
DTEND;TZID=America/New_York:20250731T220000
DTSTAMP:20250814T152135Z
CREATED:20250714T124211Z
LAST-MODIFIED:20250814T152135Z
UID:13668-1753776000-1753999200@osma.net
SUMMARY:OSMA Virtual Summer Series 2025
DESCRIPTION:Join us for the OSMA Virtual Summer Series! \nWHEN: Five sessions taking place July 29 & 31\, 2025 \nWHERE: OSMA Zoom Meeting \nREGISTRATION: Registration is free!  Please log into your member account for executive summaries and presentations. \nJuly 29th | 11:00am ET: Navigating India’s Healthcare Landscape: A Market Entry Guide for Global Healthtech Manufacturers \nThis insightful 60-minute session with Dr. Viraj Vaidya (bttn) will provide a quick overview of India’s healthcare product approval landscape (CDSCO\, ICMR\, BIS)\, highlight recent regulatory trends\, and share practical strategies for global healthtech manufacturers entering the Indian market. We’ll cover classification\, approval pathways\, and market entry playbooks\, along with examples and visuals to illustrate key points. \nJuly 29th | 7:00pm ET: Japan’s Medical Device Regulatory Environment: PMDA Pathways and Market Entry Strategies for Orthopedic Manufacturers \nThis 60-minute session with Philip O’Neill (Parkdale Group) will provide a comprehensive overview of Japan’s medical device regulatory environment\, focusing on the PMDA and key approval pathways for market entry. We’ll examine common pitfalls and share practical tips for companies new to the Japanese market\, along with strategic insights that can benefit experienced manufacturers looking to optimize their approach. \nJuly 31st | 12:00pm ET: Real World Evidence in Healthcare: Insights and Applications from NEST \nThis 60-minute session will provide an overview of NEST’s role in advancing real-world evidence for medical device manufacturers. The presentation will cover who NEST is and their partnership with MDIC\, followed by an explanation of the NESTcc Mark process and how it helps streamline regulatory submissions. Attendees will learn about NEST’s data partner network and how they support evidence generation\, along with real-world examples of successful regulatory submissions including recent PMA approvals and 510(k) clearances across various therapeutic areas. The session will conclude with insights on why partnering with NEST can help manufacturers navigate the FDA review process more effectively\, including their unique ability to address medical reviewer concerns early in the submission process.  We will be joined by Madhu Shetty\, Cori Maegley\, MBA\, MS\, Jill Dreyfus\, PhD\, MPH\, and Jemin Dedania\, MBA\, MS\, RAC. \nJuly 31st | 1:00pm ET: OSMA Business Meeting \nThis 60-minute session will provide OSMA members with comprehensive updates on organizational activities and strategic initiatives. The meeting will feature officer reports and key OSMA updates\, followed by a review of the strategic partner program and discussion of collaborative efforts with other trade associations. Attendees will receive updates on the working group program and participate in planning discussions for future meetings\, including details about the upcoming fall meeting at FDA. This business session offers an essential opportunity for members to stay informed on OSMA’s direction and provide input on organizational priorities. \nJuly 31st | 8:00pm ET: APAC Medical Device Regulatory Landscape: Strategic Pathways for China\, Korea\, and Southeast Asia Markets \nThis comprehensive 2-hour session will feature subject matter experts from Johnson & Johnson MedTech providing in-depth insights into key APAC market regulatory frameworks. The session will begin with an overview of APAC go-to-market regulatory strategy\, followed by detailed presentations on the regulatory landscapes in China\, South Korea\, and Singapore & Southeast Asia. Each country-specific segment will include dedicated time for Q&A\, allowing attendees to engage directly with subject matter experts who have extensive experience navigating these complex markets. This session is essential for medical device manufacturers looking to understand regulatory pathways\, current requirements\, and strategic approaches for successful market entry across the diverse APAC region. We will be joined by Daniel Moelands\, PharmD\, MBA (VP RA APAC)\, SeongHee Byun (RA Manager Korea)\, Kai Chang Khoo (Regulatory Affairs Lead Singapore)\, and Elaine Wu (Regulatory Affairs Director China). \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
URL:https://osma.net/event/osma-virtual-summer-series-2/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/06/2INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES-1800-x-1800-px.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250729T080000
DTEND;TZID=America/New_York:20250731T220000
DTSTAMP:20251007T035219Z
CREATED:20250616T195235Z
LAST-MODIFIED:20251007T035219Z
UID:13619-1753776000-1753999200@osma.net
SUMMARY:OSMA Virtual Summer Series 2025
DESCRIPTION:Join us for the OSMA Virtual Summer Series! \nWHEN: Five sessions taking place July 29 & 31\, 2025 \nWHERE: OSMA Zoom Meeting \nREGISTRATION: Registration has closed.  Please see below for presentations. \nJuly 29th | 11:00am ET: Navigating India’s Healthcare Landscape: A Market Entry Guide for Global Healthtech Manufacturers \nThis insightful 60-minute session with Dr. Viraj Vaidya (bttn) and Dr. Premnath Venugopalan (CSIR-NCL) will provide a quick overview of India’s healthcare product approval landscape (CDSCO\, ICMR\, BIS)\, highlight recent regulatory trends\, and share practical strategies for global healthtech manufacturers entering the Indian market. We’ll cover classification\, approval pathways\, and market entry playbooks\, along with examples and visuals to illustrate key points. \nPresentation: Breaking into India- Healthcare Product Approvals & Market Entry Strategy \nIndia Session Executive Summary \n  \nJuly 29th | 7:00pm ET: Japan’s Medical Device Regulatory Environment: PMDA Pathways and Market Entry Strategies for Orthopedic Manufacturers \nThis 60-minute session with Philip O’Neill (Parkdale Group) will provide a comprehensive overview of Japan’s medical device regulatory environment\, focusing on the PMDA and key approval pathways for market entry. We’ll examine common pitfalls and share practical tips for companies new to the Japanese market\, along with strategic insights that can benefit experienced manufacturers looking to optimize their approach. \nPresentation: Regulatory Landscape and Market Entry Strategies in Japan \nJapan Session Executive Summary \n  \nJuly 31st | 12:00pm ET: Real World Evidence in Healthcare: Insights and Applications from NEST \nThis 60-minute session will provide an overview of NEST’s role in advancing real-world evidence for medical device manufacturers. The presentation will cover who NEST is and their partnership with MDIC\, followed by an explanation of the NESTcc Mark process and how it helps streamline regulatory submissions. Attendees will learn about NEST’s data partner network and how they support evidence generation\, along with real-world examples of successful regulatory submissions including recent PMA approvals and 510(k) clearances across various therapeutic areas. The session will conclude with insights on why partnering with NEST can help manufacturers navigate the FDA review process more effectively\, including their unique ability to address medical reviewer concerns early in the submission process.  We will be joined by Madhu Shetty\, Cori Maegley\, MBA\, MS\, Jill Dreyfus\, PhD\, MPH\, and Jemin Dedania\, MBA\, MS\, RAC. \nReal World Evidence with NEST \nRWE/NEST Session Executive Summary \n  \nJuly 31st | 1:00pm ET: OSMA Business Meeting \nThis 60-minute session will provide OSMA members with comprehensive updates on organizational activities and strategic initiatives. The meeting will feature officer reports and key OSMA updates\, followed by a review of the strategic partner program and discussion of collaborative efforts with other trade associations. Attendees will receive updates on the working group program and participate in planning discussions for future meetings\, including details about the upcoming fall meeting at FDA. This business session offers an essential opportunity for members to stay informed on OSMA’s direction and provide input on organizational priorities. \n  \nJuly 31st | 8:00-10:00pm ET: APAC Medical Device Regulatory Landscape: Strategic Pathways for China\, Korea\, and Southeast Asia Markets \nThis comprehensive 2-hour session will feature subject matter experts from Johnson & Johnson MedTech providing in-depth insights into key APAC market regulatory frameworks. The session will begin with an overview of APAC go-to-market regulatory strategy\, followed by detailed presentations on the regulatory landscapes in China\, South Korea\, and Singapore & Southeast Asia. Each country-specific segment will include dedicated time for Q&A\, allowing attendees to engage directly with subject matter experts who have extensive experience navigating these complex markets. This session is essential for medical device manufacturers looking to understand regulatory pathways\, current requirements\, and strategic approaches for successful market entry across the diverse APAC region.  We will be joined by Daniel Moelands\, PharmD\, MBA (VP RA APAC)\, SeongHee Byun (RA Manager Korea)\, Kai Chang Khoo (Regulatory Affairs Lead Singapore)\, and Elaine Wu (Regulatory Affairs Director China). \nAPAC Session Executive Summary \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net
URL:https://osma.net/event/osma-virtual-summer-series/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/06/2INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES-1800-x-1800-px.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250422T183000
DTEND;TZID=America/Los_Angeles:20250424T163000
DTSTAMP:20250523T151921Z
CREATED:20250211T202320Z
LAST-MODIFIED:20250523T151921Z
UID:13311-1745346600-1745512200@osma.net
SUMMARY:OSMA 2025 Spring Meeting
DESCRIPTION:Join us on the waterfront in historic Annapolis\, Maryland for three days of networking and education as we explore the global regulatory landscape in Digital Health. \nWHEN: Tuesday\, April 22- Thursday\, April 24 \nWHERE: Annapolis\, Maryland \nREGISTRATION: Log in to the Member Site to access the registration link. \nHOTEL: A discounted hotel rate of $259 has been reserved for meeting attendees.  Log into the member site to access the hotel block link. \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net \nAGENDA: Log into the Member Site to access the full agenda. \nOVERVIEW: \nTuesday\, April 22– Please join us for an evening Networking Reception at the Annapolis Waterfront Hotel.  This is a great chance to reconnect with other OSMA members! \n      \n  \nWednesday\, April 23– We will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on the global digital health regulatory landscape: \n\nDigital Health Revolutions:\n\nDiscover how key trends including care dispersion\, cost pressures\, and digitalization are reshaping the MedTech landscape\nLearn strategies for building a digital core and leveraging digital capabilities to navigate industry challenges\nExplore evolving reimbursement models and partnership strategies\, with insights applicable to orthopedics\nUnderstand the emerging impact of AI and agentic AI technologies on orthopedic innovation and patient care\n\n\nAI/ML Lifecycle: PCCPs\, Updated regulatory guidance\, and more!\nPrecision in Practice: Navigating Regulatory Requirements for Patient-Specific Implants & Surgical Planning Software-\n\nRegulatory Pathways: Navigating FDA submissions and recent guidance updates.\nTesting & Validation: FDA expectations for mechanical testing\, biocompatibility\, and software validation\, including AI/ML-based applications.\nSaMD vs. Integrated Submissions: Evaluating the benefits and challenges of separating pre-operative planning software as SaMD.\n\n\n\nLater that evening\, take a stroll down to the Choptank Annapolis for our private event in the Commodore’s Room. \n      \n  \nThursday\, April 24– The final day of the meeting is packed with education sessions that include even more digital health topics: \n\nEuropean Regulatory Trends in Medical Devices: Navigating the AI/ML Act\, Cybersecurity Essentials\nRevolutionizing Orthopedic Device Testing: In Silico Trials- Future Digital Methods to Reduce Cost and Time to Market\, Digital Twins\nSmart Implants\, Sensor Technology\, Wearable Sensors\nDigitalization in Regulatory\, Quality\, and Clinical Documentation\n\n  \n      \nWe can’t wait to see you in Annapolis!
URL:https://osma.net/event/osma-2025-spring-meeting-2/
LOCATION:Annapolis Waterfront Hotel\, 80 Compromise St.\, Annapolis\, MD\, 21401\, United States
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/01/Blue-boat-header.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250422T183000
DTEND;TZID=America/Los_Angeles:20250424T163000
DTSTAMP:20251007T034946Z
CREATED:20250127T192351Z
LAST-MODIFIED:20251007T034946Z
UID:13163-1745346600-1745512200@osma.net
SUMMARY:OSMA 2025 Spring Meeting
DESCRIPTION:Join us on the waterfront in historic Annapolis\, Maryland for three days of networking and education as we explore the global regulatory landscape in Digital Health. \nWHEN: Tuesday\, April 22- Thursday\, April 24 \nWHERE: Annapolis Waterfront Hotel\, Annapolis\, Maryland \nREGISTRATION: Update: Registration has ended. \n\nMembers- please choose the “member” ticket type\nStrategic Partners- please choose the “strategic partner” ticket type\n\nHOTEL:  Update: The hotel block has closed. \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net \nPRESENTATIONS: \nExecutive Summary Day One Spring 2025 \nExecutive Summary Day Two Spring 2025 \nTrack One: Digital Health Revolution- Key Trends Shaping the MedTech Evolution \nTrack 1- Oliver Richards and Jens Lauber \nTrack Two: Digitalization in Regulatory\, Quality\, and Clinical Documentation \nTrack 2a – Amra Racic \nTrack 2b – Martin Witte \nTrack 2c – Jens Lauber \nTrack 2d – Conor Hogan \nTrack Three: Unlocking AI Innovations- Navigating FDA’s Guidance Documents for AI/ML Enabled Devices. \nTrack 3 – Manan Hathi\, Ganesh Saiprasad\, Diane Johnson\, Anupama Govindarajan \nTrack Four: Precision in Practice: Navigating Regulatory Requirements for Patient-Specific Implants & Surgical Planning Software. \nTrack 4 – Dave McGurl and Nima Akhlaghi \nTrack Five: Emerging European Regulatory Trends for AI/ML Medical Devices. \nTrack 5a – Erik Vollebregt \nTrack 5b – Jens Lauber \nTrack 5c – Conor Hogan \nTrack Six: Revolutionizing Orthopedic Device Evaluation with In-Silico Evidence \nTrack 6a – Cheryl Liu \nTrack 6b – Luca Emili  \nTrack 6c- Marc Horner \nTrack 6d- Payman Ashfari \nTrack 6e- Mathieu Rimaud \nTrack Seven: Smart Implants: New Generational Implants\, Devices\, and Sensor Technology \nTrack 7 – Garrett O’Lochlainn and Andrew Fields \nTrack Eight: Post-Market Surveillance and Real World Evidence: Challenges and Opportunities in an Era of Regulatory Change and Technological Advancement \nTrack 8a – Jens Lauber \nTrack 8b – Heather Colvin \nTrack 8c- Diane Legere \n  \nAGENDA: Agenda for the OSMA 2025 Spring Meeting \nOVERVIEW: \nTuesday April 22– Please join us at 7pm for an evening Networking Reception at the Annapolis Waterfront Hotel.  This is a great chance to reconnect with other OSMA members! \n      \n  \nWednesday\, April 23– We will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on the global digital health regulatory landscape: \n\nDigital Health Revolution:\n\nDiscover how key trends including care dispersion\, cost pressures\, and digitalization are reshaping the MedTech landscape.\nLearn strategies for building a digital core and leveraging digital capabilities to navigate industry challenges.\nExplore evolving reimbursement models and partnership strategies\, with insights applicable to orthopedics.\nUnderstand the emerging impact of AI and agentic AI technologies on orthopedic innovation and patient care.\n\n\n\n  \n\n\nDigitalization in Regulatory\, Quality\, and Clinical Documentation \n\nMethods applied by the medical device industry to increase efficiency. \nFrom application to certification\, the value of digital methods. \nCurrent practices and future opportunities. \n\n\n\n  \n\n\nUnlocking AI Innovations- Navigating FDA’s Guidance Documents for AI/ML Enabled Devices. \n\nRegulatory Insights on Lifecycle Management of AI-enabled Devices\nIntroduction of AI-DSF into Clinical Workflows\nR&D of AI-enabled Devices – Development\, Data\, and Interoperability\nPCCP – Background and Expectations\n\n\n\n  \n\nPrecision in Practice: Navigating Regulatory Requirements for Patient-Specific Implants & Surgical Planning Software-\n\nRegulatory Pathways: Navigating FDA submissions and recent guidance updates.\nTesting & Validation: FDA expectations for mechanical testing\, biocompatibility\, and software validation\, including AI/ML-based applications.\nSaMD vs. Integrated Submissions: Evaluating the benefits and challenges of separating pre-operative planning software as SaMD.\n\n\n\n  \nLater that evening\, take a stroll down to the Choptank Annapolis for our private event in the Commodore’s Room. \n      \n  \nThursday\, April 24– The final day of the meeting is packed with education sessions that include even more digital health topics: \n\nEuropean Regulatory Trends in Medical Devices:\n\nNavigating the EU AI/ML Act\nCybersecurity/QMS Integration\nCybersecurity Essentials- Requirements and Security by Design & Testing\n\n\n\n  \n\nRevolutionizing Orthopedic Device Testing: In Silico Trials- Future Digital Methods to Reduce Cost and Time to Market\, Digital Twins\n\n  \n\nSmart Implants\, Sensor Technology\, Wearable Sensors\n\nIntroduction to sensor technology/smart implants and the regulatory challenges\nConsiderations for active implantable medical devices (radio\, battery\, software\, hazardous substances etc.)\nRegulatory considerations for sensors in medical devices; wearable sensors in the orthopedic space\n\n\n\n  \n\nPost-Market Surveillance: Challenges and Opportunities in an Era of Regulatory Change and Technological Advancement\n\nRegulatory landscape and trends (MDR & IVDR Challenges\, Active surveillance program from FDA/NEST\, IMDRF’s Global Harmonization Efforts)\nDigital Transformation & Automation (AI & Machine Learning in PMS\, Automating Complaint Handling & Signal Detection\, Natural Language Processing (NLP) for PMS)\nReal-World Data (RWD) & Post-Market Evidence Generation (Leveraging RWD for PMS\, Predictive Risk Management\, Data Quality based on Standardization and Interoperability)\nSurveillance Beyond Compliance – Closed Quality Loop & Patient Outcomes (Proactive vs. Reactive PMS Strategies\, Customer Feedback Loops\, Patient-Centric Surveillance)\n\n\n\n  \n      \nWe can’t wait to see you in Annapolis!
URL:https://osma.net/event/osma-2025-spring-meeting/
LOCATION:Annapolis Waterfront Hotel\, 80 Compromise St.\, Annapolis\, MD\, 21401\, United States
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/01/Blue-boat-header.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250121T183000
DTEND;TZID=America/Los_Angeles:20250123T163000
DTSTAMP:20250711T063126Z
CREATED:20241230T174248Z
LAST-MODIFIED:20250711T063126Z
UID:12943-1737484200-1737649800@osma.net
SUMMARY:OSMA 2025 Winter Meeting
DESCRIPTION:Join us in sunny Orlando\, FL for three days of networking and education as we explore the regulatory landscape outside of the United States. \nWHEN: Tuesday\, January 21- Thursday\, January 23 \nWHERE: Orlando\, FL \nAGENDA: Please log into your member account to access the latest agenda. \nREGISTRATION: Please log into your member account to access the registration link. \nHOTEL: Renaissance Orlando at SeaWorld ($299/nt + taxes/fees).  The discounted hotel rate ends January 3rd\, 2025.  Please log in to your member account to access the hotel block link. \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net \nTuesday January 21– Please join us for an evening Networking Reception at the Upper Deck at the Renaissance Orlando at SeaWorld.  This is a great chance to reconnect with other OSMA members! \n      \n  \nWednesday\, January 22– We will kick off the day with the OSMA Business Meeting followed by Education Sessions addressing the impact of MDR in other countries such as Australia\, Canada\, the UK\, and Switzerland.  Later that evening\, we will dine with the sharks at the SeaWorld Sharks Underwater Grill! \n \n  \nThursday\, January 23– The final day of the meeting is packed with education sessions that include topics such as future MDR legislative changes\, alignment of notified bodies with the Code of Conduct\, Structured Dialogue and more. This day will also include panel sessions with representatives from Team NB and several notified bodies. \n       \nWe can’t wait to see you in Orlando!
URL:https://osma.net/event/osma-2025-winter-meeting-2/
LOCATION:Renaissance Orlando at SeaWorld\, 6677 Sea Harbor Drive\, Orlando\, FL\, 32821
ATTACH;FMTTYPE=image/jpeg:https://osma.net/wp-content/uploads/2024/12/2025-Winter-Meeting-2160-x-1080-px-scaled.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250121T183000
DTEND;TZID=America/Los_Angeles:20250123T163000
DTSTAMP:20251007T014522Z
CREATED:20241230T170934Z
LAST-MODIFIED:20251007T014522Z
UID:12917-1737484200-1737649800@osma.net
SUMMARY:OSMA 2025 Winter Meeting
DESCRIPTION:Join us in sunny Orlando\, FL for three days of networking and education as we explore the regulatory landscape outside of the United States. \nWHEN: Tuesday\, January 21- Thursday\, January 23 \nWHERE: Orlando\, FL \nAGENDA: OSMA 2025 Winter Meeting \nREGISTRATION: OSMA Winter Meeting EventBrite Registration \nHOTEL: Renaissance Orlando at SeaWorld ($299/nt + reduced taxes/fees).  The discounted hotel rate ends January 3rd\, 2025. https://book.passkey.com/event/50938475/owner/210/home \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net \nPRESENTATIONS: \nAndrea Pietsch\, PhD: UKCA Updates \nIbim Tariah\, PhD: Impact of MDR in Switzerland \nDaniel Yoon: Health Canada eSTAR \nMerlin Rietschel: MDR Implementation with MedTech Europe Updates \nRebecca Gaudin: Australian Regulatory Landscape \nDr. Adina Hayek (TGA): Australian Regulatory Landscape- Clinical Evidence Requirements \nPurvi Patel: Team NB Presentation \nBalazs Bozsik: Structured Dialog \nAndrea Pietsch and Dan Hoehn: Renewal & Transfer \nErik Vollebregt: Future of Medical Devices Regulations \nExecutive Summary Day One Winter Meeting 2025 \nExecutive Summary Day Two Winter Meeting 2025 \n  \nOVERVIEW: \nTuesday January 21– Please join us for an evening Networking Reception on the Upper Deck at the Renaissance Orlando at SeaWorld.  This is a great chance to reconnect with other OSMA members! \n      \n  \nWednesday\, January 22– We will kick off the day with the OSMA Business Meeting followed by Education Sessions addressing the impact of MDR in other countries such as Australia\, Canada\, the UK\, and Switzerland.  Later that evening\, we will dine with the sharks at the SeaWorld Sharks Underwater Grill! \n \n  \nThursday\, January 23– The final day of the meeting is packed with education sessions that include topics such as future MDR legislative changes\, alignment of notified bodies with the Code of Conduct\, Structured Dialogue and more. This day will also include panel sessions with representatives from Team NB and several notified bodies. \n       \nWe can’t wait to see you in Orlando!
URL:https://osma.net/event/osma-2025-winter-meeting/
LOCATION:Renaissance Orlando at SeaWorld\, 6677 Sea Harbor Drive\, Orlando\, FL\, 32821
ATTACH;FMTTYPE=image/jpeg:https://osma.net/wp-content/uploads/2024/12/2025-Winter-Meeting-2160-x-1080-px-scaled.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20241022T183000
DTEND;TZID=America/Los_Angeles:20241024T160000
DTSTAMP:20251007T023146Z
CREATED:20240719T154341Z
LAST-MODIFIED:20251007T023146Z
UID:12398-1729621800-1729785600@osma.net
SUMMARY:OSMA 2024 Fall Meeting
DESCRIPTION:Join us in Baltimore\, MD for three days of networking\, education\, and celebrating OSMA’s 70th year of collaborative excellence! \nWHEN: Tuesday\, October 22 – Thursday\, October 24 \nWHERE: Baltimore\, MD \nAGENDA: FALL-2024-Agenda \nREGISTRATION: https://osmafall2024.eventbrite.com \nHOTEL: Baltimore Renaissance Harborplace Hotel- Room Rate: $219/nt\nhttps://book.passkey.com/e/50861002 \nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net \nPRESENTATIONS: \nCapitol Hill Update \nB1+RMS: What is it and How Does it Impact MRI Safety Labeling?  \nTrending Topics in Orthopedics \nAAOS Update from the Committee on Devices\, Biologics\, and Technology \nUnderstanding Requirements for In Silico Clinical Trials \nAccreditation Scheme for Conformity Assessment (ASCA) Program Updates \nMRI Safety Evaluations: Common Deficiency Questions \nFDA Updates: Inspections and Compliance \nDe Novo Decision Analysis \nFDA Digital Health Insights \nDigital Health Insights- Industry Perspective \nTable Topic Discussion \nNotes from Fall 2024 Day One Business & Education \nNotes from Fall 2024 Day Two Education \nExecutive Summary Day One  \nExecutive Summary Day Two  \nOSMA Fireside Chat Meeting Minutes
URL:https://osma.net/event/osma-2024-fall-meeting/
LOCATION:The Renaissance Harborplace Hotel\, 202 E Pratt Street\, Baltimore\, 21202\, United States
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2024/07/fall.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240611T080000
DTEND;TZID=America/Los_Angeles:20240613T130000
DTSTAMP:20251007T022508Z
CREATED:20240501T172624Z
LAST-MODIFIED:20251007T022508Z
UID:12136-1718092800-1718283600@osma.net
SUMMARY:OSMA 2024 Summer Meeting
DESCRIPTION:Join us in Chicago\, IL at the annual OMTEC Expo for our OSMA Summer Business Meeting\, OSMA-Sponsored Education Sessions\, and access to nearly 200 exhibiting companies including suppliers and consultants. \nAGENDA\nOSMA-Sponsored Educations Sessions will take place the afternoon of Tuesday\, June 11th.\nREGISTRATION is closed\nPlease note that when registering\, OSMA members will see an exclusive registration option appear after selecting their member company. This OSMA-specific registration option allows you access to the business meeting Tuesday morning (June 11th).\nEXHIBITORS \nSPEAKER PRESENTATIONS\nConquer-the-MDR-Maze-Expert-Insights-and-Real-World-Examples\nMastering-Biocompatibility-Testing-in-a-Shifting-Landscape\nNavigating-Global-Audit-Landscape\nProven-Ways-to-Overcome-Todays-Top-Regulatory-Challenges \n 
URL:https://osma.net/event/osma-2024-summer-meeting/
LOCATION:Donald E. Stephens Convention Center 5555 N River Rd\, Rosemont\, IL 60018\, 5555 N River Rd\, Rosemont\, IL\, 60018\, United States
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2024/05/omtec-logo.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240422T190000
DTEND;TZID=America/Los_Angeles:20240424T153000
DTSTAMP:20251007T022203Z
CREATED:20240306T141048Z
LAST-MODIFIED:20251007T022203Z
UID:11874-1713812400-1713972600@osma.net
SUMMARY:OSMA 2024 Spring Meeting
DESCRIPTION:Join us in National Harbor\, MD for three days of networking\, education\, and celebrating OSMA’s 70th year of collaborative excellence! \nWHEN: Monday\, April 22 – Wednesday\, April 24\nWHERE: National Harbor\, MD\nAGENDA: Spring 2024 Agenda\nREGISTRATION: CLOSED\nHOTEL: CLOSED\nSUBMIT SPEAKER QUESTIONS TO: mpc@osma.net\nPRESENTATIONS:\nUS Digital Health Regulatory Landscape\nEU Digital Health Regulatory Landscape\nExisting and Future Digital Health Needs in Orthopaedics\nAI ML Industry Submission Experience\nPCCP New Legislation Overview & Applications\nMonitoring for Bias in Clinical AI\nOpportunities to Advance Health Equity\nCybersecurity FDA Requirements Overview\nCybersecurity Considerations for Legacy Devices\nFDA Guidance Computational Modeling Overview\nIn Silico Clinical Trials\nSubmission Best Practices & Considerations for Sensor Technology\nMedical Extended Reality – Applications and Challenges\nIndustry Perspective on Extended Reality
URL:https://osma.net/event/osma-2024-spring-meeting/
LOCATION:Gaylord National Resort & Convention Center\, 201 Waterfront Street\, National Harbor\, MD\, 20745\, United States
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20240129T190000
DTEND;TZID=America/Los_Angeles:20240131T150000
DTSTAMP:20251007T021629Z
CREATED:20231215T082416Z
LAST-MODIFIED:20251007T021629Z
UID:10163-1706554800-1706713200@osma.net
SUMMARY:OSMA 2024 Winter Meeting
DESCRIPTION:Join us in Charleston\, SC for three days of networking\, education\, and celebrating OSMA’s 70th year of collaborative excellence! \nWHEN: Monday\, January 29 – Wednesday\, January 31 \nWHERE: Charleston\, SC \nAGENDA: WINTER 2024 Agenda \nPRESENTATIONS: \nThe Regulatory Landscape in Europe_Akra \nMDR Implementation_State of Play_Rietschel \nUKCA Update and Comparison to MDR Process and Documentation Requirements_Marriott \nMDR Transitional Period Extension_Gao \nRegulatory Pathways for Custom Made and Patient Matched Devices_Pietsch \nClinical Conformity Routes for Orthopaedic Devices_Gulkin \nKey Clinical\, SSCP and PMSPMCF NonConformities Raised by Notified Bodies_Fink \nClinical Consultation Process_First Experience with the Expert Panel_Marriott \nUse of Real World Evidence during EU Submissions_Hufford \nChanges Management_Brodrick \nImpact of Classification Changes_Brodrick \n  \n  \n 
URL:https://osma.net/event/osma-2024-winter-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20231023T183000
DTEND;TZID=America/New_York:20231026T183000
DTSTAMP:20250423T001448Z
CREATED:20231006T044514Z
LAST-MODIFIED:20250423T001448Z
UID:2231-1698085800-1698345000@osma.net
SUMMARY:2023 OSMA Fall Quarterly Meeting
DESCRIPTION:The 2023 OSMA Fall Quarterly Meeting will kick-off on Tuesday\, October 24 with an evening networking reception. Wednesday is packed with educational content on clinician perspectives on notified bodies’ issues\, and opportunities to participate in OSMA Working Group sessions with the Biocompatibility\, MR Testing & Labeling\, and Anti-Infective teams. FDA’s OHT-6 joins us Thursday morning followed by a panel on challenges in the regulation of anti-infective products \nWHEN: Tuesday\, October 24 – Thursday\, October 26\, 2023\nWHERE: Bethesda Marriott\, Bethesda\, MD\nFALL 2023 Agenda
URL:https://osma.net/event/2023-fall-quarterly-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230613T120000
DTEND;TZID=America/New_York:20230615T210000
DTSTAMP:20250423T001638Z
CREATED:20230510T214336Z
LAST-MODIFIED:20250423T001638Z
UID:2021-1686657600-1686862800@osma.net
SUMMARY:Summer 2023 Quarterly Meeting
DESCRIPTION:OSMA Summer 2023 Quarterly Meeting\nMonday\, June 12 (Evening Reception) – Thursday\, June 15\, 2023\nDonald E. Stephens Convention Center\, Rosemont\, IL\n\nRegister for the OSMA Summer Meeting (to be held the morning of June 13)\, and\, for a single OSMA registration fee\, you will also be able to attend OMTEC 2023 – The Orthopaedic Manufacturing & Technology Exposition and Conference (June 13-15). OMTEC is attended by product development\, procurement\, supply chain\, operations\, R&D\, and C-level executives\, as well as business development\, regulatory and QA professionals. Last year\, over 1\,000 orthopedic-focused professionals attended OMTEC.\nMeeting Registration: https://www.eventbrite.com/e/o…\nHotel Information: Attendees must make their own reservations.\nOMTEC has negotiated meeting rates at three properties:\nHyatt Regency O’Hare\nEmbassy Suites\nDoubleTree
URL:https://osma.net/event/summer-2023-quarterly-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230411T040000
DTEND;TZID=America/New_York:20230413T040000
DTSTAMP:20250423T001646Z
CREATED:20230301T033132Z
LAST-MODIFIED:20250423T001646Z
UID:2022-1681185600-1681358400@osma.net
SUMMARY:Spring 2023 Quarterly Meeting
DESCRIPTION:The OSMA Spring 2023 Quarterly Meeting will be held in the Washington\, DC area on Wednesday\, April 12 & Thursday\, April 13. Join us for a networking reception on Tuesday\, April 11th. \nRegistration: https://www.eventbrite.com/e/o… \nHotel Reservations: https://tinyurl.com/34s4xdks \n(OSMA rate of $269/night valid until April 9th or block is full) \nAgenda: Spring 2023 Please send questions for the MR Testing & Labeling Panel and the Compatibility Panel to mpc@osma.net
URL:https://osma.net/event/spring-2023-quarterly-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230411T040000
DTEND;TZID=America/New_York:20230413T040000
DTSTAMP:20250423T001653Z
CREATED:20230301T033132Z
LAST-MODIFIED:20250423T001653Z
UID:2040-1681185600-1681358400@osma.net
SUMMARY:Spring 2023 Quarterly Meeting
DESCRIPTION:The OSMA Spring 2023 Quarterly Meeting will be held in the Washington\, DC area on Wednesday\, April 12 & Thursday\, April 13. Join us for a networking reception on Tuesday\, April 11th. \nRegistration: https://www.eventbrite.com/e/o… \nHotel Reservations: https://tinyurl.com/34s4xdks \n(OSMA rate of $269/night valid until April 9th or block is full) \nAgenda: Spring 2023 Please send questions for the MR Testing & Labeling Panel and the Compatibility Panel to mpc@osma.net
URL:https://osma.net/event/spring-2023-quarterly-meeting-2/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20230125T050000
DTEND;TZID=America/New_York:20230126T050000
DTSTAMP:20250423T001704Z
CREATED:20221216T035545Z
LAST-MODIFIED:20250423T001704Z
UID:2041-1674622800-1674709200@osma.net
SUMMARY:Winter 2023 Meeting
DESCRIPTION:2023 OSMA Winter Meeting\nRegistration is now open for our in-person meeting in Miami\, FL. Registration for the two-day meeting is $495 and includes all programming\, a reception Tuesday evening\, breakfast and lunch on Wednesday and Thursday\, and a group dinner on Wednesday evening.\nAttendees must book their hotel room using the link provided. OSMA has reserved a block at 289 USD per night. A discounted resort fee of 20.00 USD will be applied at check in and includes wifi in guest rooms\, meeting spaces\, and public areas of the hotel\, as well as beach access and service\, access to the 24-hour fitness center and more.\nREGISTER: https://www.eventbrite.com/e/2…\nRESERVATIONS: https://www.marriott.com/event…\nWHEN: Wednesday\, January 25 – Thursday\, January 26\, 2023\nWHERE: Royal Palm South Beach\, Miami\, FL\nWHAT: Join us for an Expert Panel of Notified Bodies and Regulatory Pros from Europe to discuss MDR Best Practices. Also debuting the 2023-2026 OSMA Board of Directors!
URL:https://osma.net/event/winter-2023-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20221102T040000
DTEND;TZID=America/New_York:20221103T040000
DTSTAMP:20250423T001712Z
CREATED:20220720T051142Z
LAST-MODIFIED:20250423T001712Z
UID:2042-1667361600-1667448000@osma.net
SUMMARY:2022 Fall Meeting
DESCRIPTION:Save the date for the 2022 Fall Meeting. FDA OHT-6 will provide updates and discussions and the Business Meeting will include the election of the next OSMA Board of Directors\, with terms beginning January 2023.
URL:https://osma.net/event/2022-fall-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220720T120000
DTEND;TZID=America/New_York:20220720T164500
DTSTAMP:20250423T001719Z
CREATED:20220720T050858Z
LAST-MODIFIED:20250423T001719Z
UID:2043-1658318400-1658335500@osma.net
SUMMARY:2022 Summer Meeting
DESCRIPTION:SUMMER Agenda and Bios
URL:https://osma.net/event/2022-summer-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220427T130000
DTEND;TZID=America/New_York:20220428T200000
DTSTAMP:20250423T001731Z
CREATED:20220406T054752Z
LAST-MODIFIED:20250423T001731Z
UID:2044-1651064400-1651176000@osma.net
SUMMARY:2022 Spring Meeting
DESCRIPTION:Save the Date!\nOSMA’s Spring 2022 Meeting\nWednesday\, April 27 & Thursday\, April 28\nREGISTRATION: https://osmaspr22.eventbrite.c…\n2022 OSMA Spring Meeting Agenda DAY 1\n2022 OSMA Spring Meeting Agenda DAY 2
URL:https://osma.net/event/2022-spring-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220126T050000
DTEND;TZID=America/New_York:20220127T050000
DTSTAMP:20250423T001739Z
CREATED:20211202T081154Z
LAST-MODIFIED:20250423T001739Z
UID:2045-1643173200-1643259600@osma.net
SUMMARY:2022 Winter Meeting
DESCRIPTION:WHEN: Wednesday\, January 26 & Thursday\, January 27\, 2022 \nWHERE: Zoom – links will be distributed before the meeting \nREGISTRATION: https://www.eventbrite.com/e/o… \nSPEAKER QUESTIONS: Submit to mpc@osma.net no later than December 23\, 2021.
URL:https://osma.net/event/2022-winter-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20211027T040000
DTEND;TZID=America/New_York:20211028T040000
DTSTAMP:20250423T001748Z
CREATED:20210930T071756Z
LAST-MODIFIED:20250423T001748Z
UID:2046-1635307200-1635393600@osma.net
SUMMARY:2021 Fall Meeting
DESCRIPTION:WHERE: Webex \nOSMA Member Registration: https://www.eventbrite.com/e/o… \nSpeaker questions can be submitted to mpc@osma.net with FALL QUESTIONS in the subject line. Please send your questions in no later than Friday\, October 22nd.
URL:https://osma.net/event/2021-fall-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20210720T040000
DTEND;TZID=America/New_York:20210721T040000
DTSTAMP:20250423T001756Z
CREATED:20210608T225832Z
LAST-MODIFIED:20250423T001756Z
UID:2047-1626753600-1626840000@osma.net
SUMMARY:Summer 2021 Quarterly Meeting
DESCRIPTION:Registration is now open for the OSMA Summer Meeting \nhttps://osmasummer21.eventbrit… \nagenda\nagenda
URL:https://osma.net/event/summer-2021-quarterly-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20210420T040000
DTEND;TZID=America/New_York:20210421T040000
DTSTAMP:20250423T001839Z
CREATED:20210318T081555Z
LAST-MODIFIED:20250423T001839Z
UID:2048-1618891200-1618977600@osma.net
SUMMARY:Spring 2021 Quarterly Meeting
DESCRIPTION:Register Now: https://osmasp2021.eventbrite….
URL:https://osma.net/event/spring-2021-quarterly-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20210127T130000
DTEND;TZID=America/New_York:20210128T203000
DTSTAMP:20250423T002003Z
CREATED:20201030T220454Z
LAST-MODIFIED:20250423T002003Z
UID:2049-1611752400-1611865800@osma.net
SUMMARY:OSMA 2021 Winter Meeting
DESCRIPTION:Register now: https://www.eventbrite.com/e/o…\n\n\n 
URL:https://osma.net/event/osma-2021-winter-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20201113T130000
DTEND;TZID=America/New_York:20201113T180000
DTSTAMP:20250423T002003Z
CREATED:20200824T225814Z
LAST-MODIFIED:20250423T002003Z
UID:2050-1605272400-1605290400@osma.net
SUMMARY:FDA Public Workshop - Orthopaedic Device-Related Infections
DESCRIPTION:FDA has announced the first of a series of workshops focused on improving public understanding of infections related to orthopaedic devices\, including mitigation measures and the promotion of public health in this clinical area. This workshop will explore new and ongoing research\, discuss potential strategies to address associated challenges\, develop innovative solutions and foster collaboration among orthopaedic stakeholders toward the identification of regulatory science challenges related to orthopaedic device-related infections. \nAgenda and Registration: https://www.fda.gov/medical-de.. \nComments may be submitted to www.regulations.gov Docket No. # FDA-2020-N-1762 and are due by December 14\, 2020.
URL:https://osma.net/event/fda-public-workshop-orthopaedic-device-related-infections/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20201029T130000
DTEND;TZID=America/New_York:20201030T210000
DTSTAMP:20250423T002003Z
CREATED:20200528T023626Z
LAST-MODIFIED:20250423T002003Z
UID:2053-1603976400-1604091600@osma.net
SUMMARY:2020 Fall Meeting
DESCRIPTION:Virtual Meeting \nThursday\, October 29\n9:00 a.m. – 4:00 p.m. EDT \n\nOSMA Business Meeting\nMDSAP Experience Discussion\nASME V&V40\nHighlights from the FDA Spinal Devices Premarket Review Workshop\n\nFriday\, October 30\n8:00 a.m. – 5:00 p.m. EDT \n\nFDA Presentations:\n\nOHT6 Update\nBone Void Fillers\nSafety and Performance Based Guidance\nBiocompatibility and Sterility\n\n\nNESTcc Use Cases\nBreakout Discussions\n\nRegistration open until October 23rd: https://osmafall2020.eventbrit… \nSubmit speaker questions by October 5th: secretary@osma.net
URL:https://osma.net/event/2020-fall-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20200908T040000
DTEND;TZID=America/New_York:20200909T040000
DTSTAMP:20250423T002003Z
CREATED:20200729T201917Z
LAST-MODIFIED:20250423T002003Z
UID:2051-1599537600-1599624000@osma.net
SUMMARY:FDA Orthopaedic and Rehabilitation Devices Panel Meeting
DESCRIPTION:FDA has published dates for the next meeting of the Orthopaedic and Rehabilitation Devices Panel. The Panel will convene via an online platform on Tuesday\, September 8th and Wednesday\, September 9th. Per the announcement\, “during session 1\, the committee will discuss and make recommendations regarding the classification of facet screws systems which are currently unclassified pre-amendment devices to Class II (general and special controls). During session II\, the committee will discuss and make recommendations regarding the reclassification of non-invasive bone growth stimulators which are currently post-amendment devices from Class III (general controls and premarket approval) to Class II (general and special controls).” \nWebcast link for Day 1: https://fda.yorkcast.com/​webcast/​Play/​8ef8ac6b36f244beaced2a3031eebc621d. \nWebcast link for Day 2: https://fda.yorkcast.com/​webcast/​Play/​0e1b175674de4b1e8a4675cf5096aa601d. \nBackground material (posted at least two business days before the meeting): https://www.fda.gov/​advisory-committees/​medical-devices-advisory-committee/​orthopaedic-and-rehabilitation-devices-panel.
URL:https://osma.net/event/fda-orthopaedic-and-rehabilitation-devices-panel-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/svg+xml:https://osma.net/wp-content/uploads/2021/11/img-logo-mark-osma.svg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20200813T120000
DTEND;TZID=America/New_York:20200813T210000
DTSTAMP:20250423T002003Z
CREATED:20200616T230830Z
LAST-MODIFIED:20250423T002003Z
UID:2052-1597320000-1597352400@osma.net
SUMMARY:FDA Public Workshop - Spinal Devices Premarket Review
DESCRIPTION:The Food and Drug Administration (FDA) is announcing a public workshop entitled “Spinal Device Premarket Review.” The workshop is intended to enhance public understanding of FDA’s review of data and information submitted to support premarket authorization for spinal devices falling under 21 CFR 888.3070 and 21 CFR 888.3080 by highlighting key sections of a 510(k) submission. The workshop will be webcast only. \nAGENDA \nREGISTRATION
URL:https://osma.net/event/fda-public-workshop-spinal-devices-premarket-review/
LOCATION:Maryland
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20200722T040000
DTEND;TZID=America/New_York:20200723T040000
DTSTAMP:20250423T002003Z
CREATED:20200528T023428Z
LAST-MODIFIED:20250423T002003Z
UID:2054-1595390400-1595476800@osma.net
SUMMARY:2020 Summer Meeting - Webex
DESCRIPTION:Meeting Information
URL:https://osma.net/event/summer-2020-virtual-meeting/
LOCATION:Maryland
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END:VEVENT
END:VCALENDAR