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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: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
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