
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!
Registration for the Spring Meeting is now closed.
Registration: 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.
Location: 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.
Accommodations: Sign into your member account to access hotel recommendations.
Agenda: Sign into your member account to access the full agenda.
Tuesday, April 21 | 12:00 PM
- OSMA Business Meeting: Board Updates, Officer Reports, Website Updates, and Working Group Updates
- OAR Think Tank
- Evening Networking Reception at YardHouse
Wednesday, April 22: Education Sessions
- Washington Policy Update- Clayton Hall, MDMA
- MedTech Europe Update- Merlin Rietschel, MedTech Europe
- Innovation in Clinical Study Design- Nick Giokas, MCRA
- Reimbursement Strategies- John McDermott Jr., MCRA
- The Use of Data and AI to Improve Surgical Outcomes- Andrew Fields, Medtronic
- The Mirror Effect: Mirroring the FDA’s AI Maturity to Avoid the Transparency Gap- Amra Racic, Veeva MedTech
- Unboxing Orthopedics: Why Packaging Can Make or Break Safety- Christina Mendat,
- What’s New in ISO 10993-1:2025? Implications for Biological Evaluation Programs- Sainath Babu, MED Institute
- Current Biocompatibility Requirements are Stifling Innovation and Impeding Device Development – What Can We Do About It?- Ron Brown, Risk Science Consortium
- Common Pitfalls in Biocompatibility Submissions for Medical Devices: Insights from 100 Notified Body Technical File Assessments- Shahriar Sharifi, GMED
- Evening Group Dinner at Zaytinya Mediterranean Restaurant
Thursday, April 23: EU/MDR Presentations and Panel Discussions
- High-level overview of the EU MDR Proposal and Annex VII Changes- Matthias Fink, Team AKRA
- Reason for this Proposal
- Impact on the Industry
- Impact on Notified Bodies
- Team NB View of Current Developments in the EU- Dan Hoehn, BSI
- EUDAMED Status Update- Jörg Rönneau, TÜV SÜD, virtual
- MDR 2.0: Administrative Burden Reductions on Reporting Obligations- Matthias Fink, Team AKRA
- New proposed Certification Process: Proportionality and Simplification Measures- Rafal Byczkowski, TÜV Rhineland
- New Clinical Evidence Requirements to Regain Attractiveness in the EU- Chris Brodrick, GMED
- Innovation and Access Pathways- Dan Hoehn, BSI
- Digitalization of Processes and Documentation in the EU- Amra Racic, Veeva MedTech and Manan Hathi, Stryker
- Breaking the mold: Annex VII and the Cultural Reset of Conformity Assessment- Ehab Amen, GMED



