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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/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/New_York:20251211T150000
DTEND;TZID=America/New_York:20251211T170000
DTSTAMP:20251218T185233Z
CREATED:20251107T191839Z
LAST-MODIFIED:20251218T185233Z
UID:13909-1765465200-1765472400@osma.net
SUMMARY:OSMA Virtual Business Meeting
DESCRIPTION:**The Executive Summary and Video Recording of the Fall Business Meeting are now available** \nThank you for attending the OSMA 2025 Fall Business Meeting. \nAgenda Topics:\n– Meet this year’s board nominees\n– Hear updates from OSMA officers\n– Review working group changes and progress\n– Preview future meeting plans\n– Learn about the OAR Relaunch\, including recent progress and new opportunities for member involvement \nThis is your chance to stay informed on OSMA’s strategic direction and contribute to shaping our organizational priorities. \n🗓️ Date: December 11\, 2025\n⏰ Time: 3:00 PM EST\n🆓 Cost: Free \nOSMA December 2025 Virtual Business Meeting Executive Summary \nVideo Recording
URL:https://osma.net/event/osma-virtual-business-meeting/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/11/Business-Conference-scaled.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251211T150000
DTEND;TZID=America/New_York:20251211T170000
DTSTAMP:20260130T160925Z
CREATED:20251107T192120Z
LAST-MODIFIED:20260130T160925Z
UID:13912-1765465200-1765472400@osma.net
SUMMARY:OSMA Virtual Business Meeting
DESCRIPTION:Thank you for attending the OSMA board for the 2025 Fall Virtual Business Meeting. \nPlease login in to view the executive summary and video recording. Need a member account?  For member companies- click here.  For strategic partners- click here \nAgenda:\n– Meet this year’s board nominees\n– Hear updates from OSMA officers\n– Review working group changes and progress\n– Preview future meeting plans\n– Learn about the OAR Relaunch\, including recent progress and new opportunities for member involvement \nThis is your chance to stay informed on OSMA’s strategic direction and contribute to shaping our organizational priorities. \n 
URL:https://osma.net/event/osma-virtual-business-meeting-2/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/11/Business-Conference-scaled.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260421T080000
DTEND;TZID=America/Los_Angeles:20260423T170000
DTSTAMP:20260409T183038Z
CREATED:20260130T161057Z
LAST-MODIFIED:20260409T183038Z
UID:13959-1776758400-1776963600@osma.net
SUMMARY:OSMA 2026 Spring Meeting
DESCRIPTION:UPDATE: Tickets are now sold out for the 2026 Spring Meeting. We hope to see you in September for our 2026 Fall Meeting with FDA! \nRegistration for the Spring Meeting is now closed. \nRegistration: The link to register can be found by logging into your member account. If you need to create an OSMA account\, click here: Member Company Account\, Strategic Partner Account. \nLocation: This year we will be hosting the meeting at the MCRA Offices in Washington D.C. This office is located at 803 7th Street NW in the Chinatown neighborhood. The MCRA office is close to several hotels and has easy access to a Metro stop. The closest airport is Reagan National Airport (DCA) which is only a few Metro stops away. \nAccommodations: Sign into your member account to access hotel recommendations. \nAgenda: Sign into your member account to access the full agenda. \n  \n \nTuesday\, April 21 | 12:00 PM \n\nOSMA Business Meeting: Board Updates\, Officer Reports\, Website Updates\, and Working Group Updates\nOAR Think Tank\nEvening Networking Reception at YardHouse\n\n \n  \nWednesday\, April 22: Education Sessions  \n\nWashington Policy Update- Clayton Hall\, MDMA\nMedTech Europe Update- Merlin Rietschel\, MedTech Europe\nInnovation in Clinical Study Design- Nick Giokas\, MCRA\nReimbursement Strategies- John McDermott Jr.\, MCRA\nThe Use of Data and AI to Improve Surgical Outcomes- Andrew Fields\, Medtronic\nThe Mirror Effect: Mirroring the FDA’s AI Maturity to Avoid the Transparency Gap- Amra Racic\, Veeva MedTech\nUnboxing Orthopedics: Why Packaging Can Make or Break Safety- Christina Mendat\, \nWhat’s New in ISO 10993-1:2025? Implications for Biological Evaluation Programs- Sainath Babu\, MED Institute\nCurrent Biocompatibility Requirements are Stifling Innovation and Impeding Device Development – What Can We Do About It?- Ron Brown\, Risk Science Consortium\nCommon Pitfalls in Biocompatibility Submissions for Medical Devices: Insights from 100 Notified Body Technical File Assessments- Shahriar Sharifi\, GMED\nEvening Group Dinner at Zaytinya Mediterranean Restaurant\n\n \n  \nThursday\, April 23: EU/MDR Presentations and Panel Discussions \n\nHigh-level overview of the EU MDR Proposal and Annex VII Changes- Matthias Fink\, Team AKRA\n\nReason for this Proposal\nImpact on the Industry\nImpact on Notified Bodies\n\n\nTeam NB View of Current Developments in the EU- Dan Hoehn\, BSI\nEUDAMED Status Update- Jörg Rönneau\, TÜV SÜD\, virtual\nMDR 2.0: Administrative Burden Reductions on Reporting Obligations- Matthias Fink\, Team AKRA\nNew proposed Certification Process: Proportionality and Simplification Measures- Rafal Byczkowski\, TÜV Rhineland\nNew Clinical Evidence Requirements to Regain Attractiveness in the EU- Chris Brodrick\, GMED\nInnovation and Access Pathways- Dan Hoehn\, BSI\nDigitalization of Processes and Documentation in the EU- Amra Racic\, Veeva MedTech and Manan Hathi\, Stryker\nBreaking the mold: Annex VII and the Cultural Reset of Conformity Assessment- Ehab Amen\, GMED\n\n 
URL:https://osma.net/event/osma-2026-spring-meeting-2/
LOCATION:MCRA Event Space\, 803 7th Street NW\, Washington\, DC\, 20001\, United States
CATEGORIES:Upcoming Event
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2026/01/Dark-OSMA-Spring-Meeting-image-scaled.png
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260421T120000
DTEND;TZID=America/Los_Angeles:20260423T170000
DTSTAMP:20260508T160327Z
CREATED:20260130T160810Z
LAST-MODIFIED:20260508T160327Z
UID:13955-1776772800-1776963600@osma.net
SUMMARY:OSMA 2026 Spring Meeting
DESCRIPTION:UPDATE: Please see below for Executive Summaries and Meeting Presentations. Some presentations will not be available until a later date as the information provided will be used in forthcoming publications. \nRegistration is now closed for the OSMA 2026 Spring Meeting. \nLocation: This year we will be hosting the meeting at the MCRA Offices in Washington D.C. This office is located at 803 7th Street NW in the Chinatown neighborhood. The MCRA office is close to several hotels and has easy access to a Metro stop. The closest airport is Reagan National Airport (DCA) which is only a few Metro stops away. \nAccommodations: Click here for a list of nearby hotels. \nAgenda: The Full Agenda is here! Final Agenda OSMA 2026 Spring Meeting \nTuesday\, April 21 | 12:00 PM \n\nOSMA Business Meeting: Board Updates\, Officer Reports\, Website Updates\, and Working Group Updates\nOAR Think Tank\n\n  \nWednesday\, April 22 | 8:00 AM- Education Sessions  \n\nWashington Policy Update– Clayton Hall\, MDMA\nMedTech Europe Update- Merlin Rietschel\, MedTech Europe\nUnboxing Orthopedics: Why Packaging Can Make or Break Safety- Christina Mendat\, \nThe Use of Data and AI to Improve Surgical Outcomes– Andrew Fields\, Medtronic\nThe Mirror Effect: Mirroring the FDA’s AI Maturity to Avoid the Transparency Gap– Amra Racic\, Veeva MedTech\nInnovation in Clinical Study Design– Nick Giokas\, MCRA\nReimbursement Strategies– John McDermott Jr.\, MCRA\nWhat’s New in ISO 10993-1:2025? Implications for Biological Evaluation Programs- Sainath Babu\, MED Institute\nCurrent Biocompatibility Requirements are Stifling Innovation and Impeding Device Development – What Can We Do About It?– Ron Brown\, Risk Science Consortium\nCommon Pitfalls in Biocompatibility Submissions for Medical Devices: Insights from 100 Notified Body Technical File Assessments- Shahriar Sharifi\, GMED\nExecutive Summary Day Two Spring 2026 4-22-26\n\n  \nThursday\, April 23 | 8:00 AM- EU/MDR Sessions \n\nHigh-level overview of the EU MDR Proposal and Annex VII Changes– Matthias Fink\, Team AKRA\n\nReason for this Proposal\nImpact on the Industry\nImpact on Notified Bodies\n\n\nTeam NB View of Current Developments in the EU– Dan Hoehn\, BSI\nEUDAMED Status Update– Jörg Rönneau\, TÜV SÜD\, virtual\nMDR 2.0: Administrative Burden Reductions on Reporting Obligations- Matthias Fink\, Team AKRA\nNew proposed Certification Process: Proportionality and Simplification Measures– Rafal Byczkowski\, TÜV Rhineland\nNew Clinical Evidence Requirements to Regain Attractiveness in the EU– Chris Brodrick\, GMED\nInnovation and Access Pathways– Dan Hoehn\, BSI\nDigitalization of Processes and Documentation in the EU- Amra Racic\, Veeva MedTech and Manan Hathi\, Stryker (This was a panel discussion- no presentation is available.)\nBreaking the Mold: Annex VII and the Cultural Reset of Conformity Assessment– Ehab Amen\, GMED\nExecutive Summary Day Three Spring 2026 4-23-26\n\n 
URL:https://osma.net/event/osma-2026-spring-meeting/
LOCATION:MCRA Event Space\, 803 7th Street NW\, Washington\, DC\, 20001\, United States
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2026/01/Dark-OSMA-Spring-Meeting-image-scaled.png
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260720T120000
DTEND;TZID=America/Los_Angeles:20260731T200000
DTSTAMP:20260807T185448Z
CREATED:20260708T181844Z
LAST-MODIFIED:20260807T185448Z
UID:14264-1784548800-1785528000@osma.net
SUMMARY:2026 Virtual Summer Series
DESCRIPTION:Big news for the OSMA Summer Meeting\nWe’re excited to announce that registration is officially open for the OSMA Virtual Summer Series taking place between July 27 and August 7! This year’s series will feature six sessions covering key regulatory and professional development topics. \n  \n\nRegistration is FREE!\nAll Member Company and Strategic Partner employees are invited to attend.\nRegistration for Sessions 1-3 is open now\, with the remaining three sessions to be announced on a rolling basis.\n\n  \nTo view sessions and registration links\, please login to your account. \nClick here to create your Individual OSMA Member account. \nClick here to create your Individual OSMA Strategic Partner account.
URL:https://osma.net/event/2026-virtual-summer-series-2/
LOCATION:Maryland
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DTSTART;TZID=America/New_York:20260730T150000
DTEND;TZID=America/New_York:20260806T140000
DTSTAMP:20260817T174907Z
CREATED:20260708T181636Z
LAST-MODIFIED:20260817T174907Z
UID:14260-1785423600-1786024800@osma.net
SUMMARY:2026 Virtual Summer Series
DESCRIPTION:Big news for the OSMA Summer Meeting\nWe’re excited to announce that registration is officially open for the OSMA Virtual Summer Series taking place between July 30 and August 6! This year’s series will feature five sessions covering key regulatory topics. \n\nRegistration is FREE!\nAll Member Company and Strategic Partner employees are invited to attend.\nRegistration for all sessions is now open!\n\n_____________________________________________________________________________________ \nSession 1: Beyond Clinical Trials: Leveraging Real-World Evidence Throughout the Medical Device Lifecycle\nJuly 30\, 2026 | 3:00 PM ET \n \nThis insightful 60-minute session with Dr. Amelia Hufford\, the Co-founder and SVP of Clinical and Regulatory Science Operations for 3Aware\, will cover: \n– Current regulatory expectations for RWE in major global markets \n– How U.S. and EU approaches to RWD acceptance and evidence requirements compare \n– How RWD supports evidence generation across the medical device lifecycle \n– The benefits and challenges of using RWD for regulatory decision-making \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 2: TGA Requirements and Expectations for Inclusion of Orthopaedic Devices on the Australian Register of Therapeutic Goods (ARTG)\nAugust 3\, 2026 | 6:00 PM ET \n\n\n\nEdwina Burns and Jie Zhou from TGA will cover the importance of robust clinical evidence and its alignment with the requirements of the Essential Principles of the Australian Therapeutic Goods Act 1989. We will discuss reliance framework that recognises certificates from comparable overseas regulators to support orthopaedic medical device inclusion on the Australian Register of Therapeutic Goods (ARTG) that are designed to enable earlier patient access in Australia. The presentation will also give an update on Australia’s Unique Device Identification (UDI) requirements. \n\nEdwina Burns\, Medical Officer\, Devices Clinical Evaluation Section\nJie Zhou\, Technical Lead\, Devices Review Management Section\nManeesha Ram\, Associate Director of Regulatory Affairs at J&J MedTech ANZ\, will provide introductions.\n\nPresentation \nExecutive Summary \n_____________________________________________________________________________________\n\n\nSession 3: Canadian Regulatory Landscape \nAugust 4 | 11:00 AM ET \n \nJoin Nicholas Wilson from Johnson and Johnson as he provides an overview of the regulatory landscape\, highlights the latest updates\, and answers your questions. \nTopics include: \n\n\nRegulations \n\n\nGeneral Risk Based Classification \n\n\nNuanced Classification Rules \n\n\nSpecial Access and Custom-Made Devices \n\n\nTerms of Marketing Authorizations (Advertising) \n\n\nMDSAP ISO 13485 Certification and Regulatory Reliance \n\n\nIMDRF Submission Format \n\n\neSTAR Program \n\n\nPredetermined Change Control Plan (PCCP) \n\n\n  \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 4: OSMA Summer Business Meeting\nAugust 5 | 12:00 PM ET \n \nJoin OSMA President Ryan Belaney for a quick update on the latest OSMA news including the 2026 Fall Meeting at the FDA White Oak Campus\, the upcoming board elections\, an OAR update\, and highlights from the President’s Report. \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 5: Navigating Brazil’s Evolving Regulatory Landscape \nAugust 6 | 1:00 PM ET \n \nBrazil’s regulatory framework for medical devices continues to evolve\, making it essential for companies operating in the orthopaedic space to stay informed. This session with Karolyne Kikuchi will provide a practical look at Brazil’s regulatory environment and the journey companies can expect when bringing devices to market. \nTopics covered include:\n– Brazil overview\n– Regulatory landscape\n– The regulatory journey\n– Challenges and opportunities\n– Live Q&A \n  \nPresentation \nExecutive Summary
URL:https://osma.net/event/2026-virtual-summer-series/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2026/07/INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260921T120000
DTEND;TZID=America/New_York:20260923T130000
DTSTAMP:20261021T145322Z
CREATED:20260807T220557Z
LAST-MODIFIED:20261021T145322Z
UID:14326-1789992000-1790168400@osma.net
SUMMARY:OSMA 2026 Fall Meeting
DESCRIPTION:  \nPresentations and Executive Summary are now available. Login to view details. \nThank you for joining us September 21-23 in Bethesda\, Maryland for the 2026 OSMA Fall Meeting hosted at both the Hyatt Regency Hotel in downtown Bethesda and the FDA White Oak Campus! \n  \n \n  \nAccommodations: \nThe Hyatt Regency is located in downtown Bethesda. Please login to view accommodation information. \n  \nAgenda\nMonday\, September 21 | Hyatt Regency Rooftop Room \n12:00PM | Lunch \n1:00-5:00PM | Educations Sessions \n\nOSMA and OAR Updates | Ryan Belaney\, Phoenix Kinetics; Lisa Boyle\, Exalta; Valerie Giambanco\, Stryker; Hannah Foley\, J&J; Brianna Gabbard\, restor3d;\nMR Working Group Update | Grant Baker\, Arthrex and Lisa Boyle\, Exalta\nWhat’s New on Capitol Hill: A Legislative and Regulatory Update | Kyle Sampson\, King and Spalding\nOrthopedic Standards in Motion: ASTM F04.22 and ISO Updates | Leah Guenther\, Vice Chair ASTM F04.22 Arthroplasty Subcommittee\nQuality Management System Updates and Recent Experiences | Christine Scifert and Dawn Norman\, MRC Global\nPackaging and Labeling Updates: A Contract Packaging Perspective | Miki Velickovski and Jeffrey Zoleta\, Fruh Packaging\n\n  \n6:30-8:30PM | Welcome Reception | Hyatt Lobby Terrace \n  \n \n  \nTuesday\, September 22 | FDA White Oak Campus \nRoundtrip bus transportation will be provided from the Hyatt Regency to the FDA Campus. \n8:00PM-5:00PM | FDA Sessions \n\nOHT6 Update | RDML Peat PhD\, MPH\nEvidence Generation for Novel Medical Devices | Owen Faris PhD\nAccelerating Evidence Generation: From FDA Intent to Operational Execution | Amra Racic\, Veeva\nDHT6 A Update | Jiping Chen MD\, PhD\, MPH\nDHT6 B Update | Laurence Coyne PhD\nDHT6 C Update | Ronald Jean PhD\nAI/LLM Session | S. Raymond Golish MD\, PhD\, MBA\nTAP Program Updates | Cynthia Chang\nFDA QMSR Inspections | Keisha R. Thomas MS\, MHS\, CQA\, RAC\nDigital Health | Kathryn Drzewiecki PhD\nAdditive Manufacturing | David Hwang PhD\nAdvertising and Promotion | Deborah A. Wolf\, JD\n\n  \n6:30PM | Group Dinner at Mon Ami Gabi \n  \n \n  \nWednesday\, September 23 | Hyatt Regency Rooftop Room \n8:00AM | Breakfast \n8:30AM-1:00PM | Education Sessions \n\nMedical Device Servicing and Remanufacturing | Peter Weems\, AdvaMed\nLatest Updates on PCCPs | Diane Johnson\, J&J\nAI in the FDA-Regulated World: From Medical Devices to Regulatory Submissions | Milind Sawant PhD\, AI2Z\nISO 10993-1:2025: What’s Changed and What It Means for Orthopedic Devices | Lindsey Borton\, Private Toxicology Consultant at Gradient\nBreakthrough Device Designation: Company Experiences | Moderator: Lindsay Stafford\, Ceramtec; Panelists: Sharat Kusuma MD\, JointMedica; Ryan Belaney\, Phoenix Kinetics;  and Katherine Cooper\, King and Spalding\n\n  \nFull agenda will be available soon.  Login to view details. \n  \n \n  \n_________________________________________________________________________________________ \nRegistration \nPlease login to view registration links. \n_________________________________________________________________________________________ \nFDA Entry Requirements\nThe FDA has specific entrance requirements. You will not be permitted to enter the FDA Great Room without the appropriate identification (all attendees) and pre-submitted form (for Foreign Nationals). Please login to view the full requirements. \n_________________________________________________________________________________________ \nIf you have any questions\, please reach out to mpc@osma.net. \nClick here to create your individual OSMA Member Account. \nClick here to create your individual OSMA Strategic Partner Account. \n  \n 
URL:https://osma.net/event/osma-2026-fall-meeting-2/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260921T120000
DTEND;TZID=America/New_York:20260923T133000
DTSTAMP:20261021T145204Z
CREATED:20260807T182531Z
LAST-MODIFIED:20261021T145204Z
UID:14313-1789992000-1790170200@osma.net
SUMMARY:OSMA 2026 Fall Meeting
DESCRIPTION:  \nThank you for joining us at the OSMA Fall Meeting 2026! \nAgenda and Presentations\nFull Agenda: Final OSMA 2026 Fall Meeting Agenda \nExecutive Summary: OSMA 2026 Fall Meeting Executive Summary \nNote: Presentations are linked below.  \nMonday\, September 21 | Hyatt Regency Rooftop Room \n\n\nOSMA and OAR Updates | Ryan Belaney\, Phoenix Kinetics; Lisa Boyle\, Exalta; Valerie Giambanco\, Stryker; Hannah Foley\, J&J; Brianna Gabbard\, restor3d;  \n\n\nMR Working Group Update | Lisa Boyle\, Exalta \n\n\nWhat’s New on Capitol Hill: A Legislative and Regulatory Update | Kyle Sampson\, King and Spalding \n\n\nOrthopedic Standards in Motion: ASTM F04.22 and ISO Updates | Leah Guenther\, Vice Chair ASTM F04.22 Arthroplasty Subcommittee \n\n\nQuality Management System Updates and Recent Experiences | Christine Scifert and Dawn Norman\, MRC Global \n\n\nPackaging and Labeling Updates: A Contract Packaging Perspective | Miki Velickovski and Jeffrey Zoleta\, Fruh Packaging \n\n\n  \n \n  \nTuesday\, September 22 | FDA White Oak Campus \nNote: Presentations are not available for FDA sessions. \n8:00PM-5:00PM | FDA Sessions \n\n\nOHT6 Update | RDML Peat PhD\, MPH \n\n\nEvidence Generation for Novel Medical Devices | Owen Faris PhD \n\n\nAccelerating Evidence Generation: From FDA Intent to Operational Execution | Amra Racic\, Veeva \n\n\nDHT6 A Update | Jiping Chen MD\, PhD\, MPH \n\n\nDHT6 B Update | Laurence Coyne PhD \n\n\nDHT6 C Update | Ronald Jean PhD \n\n\nAI/LLM Session | S. Raymond Golish MD\, PhD\, MBA \n\n\nTAP Program Updates | Cynthia Chang \n\n\nAdditive Manufacturing | David Hwang PhD \n\n\nBest Practices for PCCPs for Medical Devices | Kathryn Drzewiecki PhD \n\n\nFDA QMSR Inspections | Keisha R. Thomas MS\, MHS\, CQA\, RAC \n\n\nAdvertising and Promotion | Deborah A. Wolf\, JD \n\n\n  \n6:30PM | Group Dinner at Mon Ami Gabi \n  \n \n  \nWednesday\, September 23 | Hyatt Regency Rooftop Room \nNote: Presentations are linked below. Executive Summaries will be available the week of October 12. \n\n\nMedical Device Servicing and Remanufacturing | Peter Weems\, AdvaMed \n\n\nLatest Updates on PCCPs | Diane Johnson\, J&J \n\n\nAI in the FDA-Regulated World: From Medical Devices to Regulatory Submissions | Milind Sawant PhD\, AI2Z \n\n\nISO 10993-1:2025: What’s Changed and What It Means for Orthopedic Devices | Lindsey Borton\, Private Toxicology Consultant at Gradient \n\n\nBreakthrough Device Designation: Company Experiences | Moderator: Lindsay Stafford\, Ceramtec; Panelists: Sharat Kusuma MD\, JointMedica; Ryan Belaney\, Phoenix Kinetics;  and Katherine Cooper\, King and Spalding \n\nAdditional Law 360 Paper Referenced in the Meeting: New CMS Medical Device Pathway May Have Limited Effect\n\n\n\n  \n \n  \n_________________________________________________________________________________________ \nRegistration \nRegistration is closed. \nPlease join us September 21-23 in Bethesda\, Maryland for the 2026 OSMA Fall Meeting hosted at both the Hyatt Regency Hotel in downtown Bethesda and the FDA White Oak Campus! \n_________________________________________________________________________________________ \nAccommodations: \nThe Hyatt Regency is located in downtown Bethesda. While we do not have a hotel block\, accommodations can be found at the Hyatt Regency and surrounding hotels. \nSELF PARKING\nFor those who prefer to self-park\, the ABM Parking Garage is located directly beneath the hotel (please\nnote this facility is not operated by Hyatt Regency Bethesda). The overnight parking fee is for a 24-\nhour period\, and validation through the hotel ensures access to in-and-out privileges. \n\n\nTo self-park\, please follow the signs leading to the P3 BALLROOM level of the garage.\n\nParking on the P3 level is recommended to prevent any potential difficulties when entering and exiting the hotel.\n\n\n\nUpon parking\, please enter through the Ballroom Double Door Entrance and they will walk directly into their event space. \nShould you require further guidance\, we have provided a helpful video detailing the navigation to P3 parking.\nPlease click here “Navigating to P3 Parking Video” \nFDA Day Transportation and Security\n🚍 Bus Transportation:  \n\nIf you signed up for bus transportation\, please arrive at the Hyatt Regency lobby by 7:00am.\nThe bus will transport attendees directly to Building 1.\nThe bus will return attendees to the Hyatt Regency after the meeting.\n\n🚘 Car Transportation: \n\nArrive at FDA before 7:45AM\nUse the Michelson Road entrance from New Hampshire Avenue to access the vehicle screening facility.\nPark in one of the Visitor Parking Lots\nTake the shuttle or short walk to Building 1\n\n🚘 Uber Transportation \n\nArrive at FDA by 7:50AM\nProceed directly to the Building 1 Circle off Mahan Road.\n\nOnce you arrive at Building 1\, you will proceed through security. You will need to have the proper identification (REAL ID\, passport\, LPR card). After going through security\, please wait for your OHT6 escort. \n  \nFor additional details on visiting the FDA campus visit: \nhttps://www.fda.gov/about-fda/visitor-information/getting-fda \nhttps://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map \n  \n \n  \nFDA Entry Requirements\nThe FDA has specific entrance requirements. You will not be permitted to enter the FDA Great Room without the appropriate identification (all attendees) and pre-submitted form (for Foreign Nationals). \n\n\n\nUS citizens and Lawful Permanent Residents\n\n\nNo form or prior approval is required to enter the Great Room.\n\n\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).\nVisitors must display their visitor badge at all times.\nVisitors are under observation and escorted at ALL times.\n\nDiscovery of unescorted visitor(s) can result in administrative action.\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 ID is accepted for LPRs.\nFollow guidance listed above\, as described for U.S. Citizens.\n\n\n\n\nForeign National (FN) Visitors: A Foreign National Visitor Data Request (FNVDR) form is required. \n \n\n\nSubmit the filled Foreign National Visitor Data Request Form\, due to OHT6 NLT COB\, September 14\, 2026\n\n(POC: ester.hatton@fda.hhs.gov\, copy: laurence.coyne@fda.hhs.gov) \n\nDo not submit FNVDR form more than 30 calendar days in advance (before August 24\, 2026).\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)\nFN are allowed in PUBLIC AREAS ONLY. FN are NOT allowed in employee offices or labs\nConfirm visitors display visitor badge at all times.\nVisitors are under observation and escorted at all times.\n\nDiscovery of unescorted visitor(s) can result in administrative action.\n\n\n\n  \nIf you have any questions\, please reach out to mpc@osma.net.
URL:https://osma.net/event/osma-2026-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/2026/08/2026-Fall-STD.png
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