AAMI Presents: 2021 Medical Device Standards and Regulation International Conference (Virtual)

October 18 - October 20, 2021
10:30 AM-3:15 PM

To Register: International Standards Conference 2021 | AAMI

Registration Prices: 

AAMI Member $50
Non-Member $125
Government Full-Time/Active Military* $50

Preliminary Virtual Schedule-at-a-Glance

as of August 31, 2021 - Conference held in Eastern Time Zone
Note: The preliminary schedule is subject to change, so please check back for updates.

The education sessions will be recorded and made available to registered attendees after the conference.

Monday, October 18, 2021

10:30 a.m.-10:45 a.m. - Welcome & Introductions, AAMI/BSI Staff

10:45 a.m.-11:15 a.m. - Opening Keynote - Ensuring the Safety and Effectiveness of Medical Devices Across the Product Lifecycle, Dr. Jeff Shuren, Director of the U.S. FDA/Center for Devices and Radiological Health

11:15 a.m.-12:15 p.m. - FDA Regulatory Update 1 - Update on the activities and programs of the FDA Center for Devices and Radiological Health, FDACDRH Staff

12:15 p.m.-1:00 p.m. - Lessons Learned - What the pandemic revealed about the U.S. medical devices sector and implications for the future, Linda Ricci, FDA; Abby Pratt, AdvaMed; Diane Wurzburger, GE Healthcare

1:00 p.m.-1:45 p.m. - Virtual Networking Break

1:45 p.m.-2:30 p.m. - Patient Engagement in Standards and Regulations and the Science of Patient Input, Dr. Jessie Ehrenfeld, AMA Board of Trustees, Medical College of Wisconsin

2:30 p.m.-3:15 p.m. - FDA Regulatory Update 2 - Digital Health Center of Excellence, Bakul Patel, FDA


Tuesday, October 19, 2021

10:30 a.m.-11:15 a.m. - Update on the European Medical Device Regulations, with a Focus on the In Vitro Diagnostic Regulation, Richard Bancroft, STERIS Corporation

11:15 a.m.-12:00 p.m. - Update on the Developing Regulatory Regime in the United Kingdom, Eamonn Hoxey, EV Hoxey, LTD

12:00 p.m.-12:45 p.m. - IMDRF Update and the Future of Global Efforts to Harmonize Regulatory Regimes, Melissa Torres, FDA/CDRH

12:45 p.m.-1:30 p.m. - Virtual Networking Break

1:30 p.m.-2:15 p.m. - Spotlight on the Medical Device Regulatory Coalition and the USAID COVID-19 Medical Device Regulatory Convergence Project and the Coalition for Regulatory Convergence, Medtech Sector, Steve Bipes, Advamed; Sandra Ligiad Gonzalez, Executive Secretary of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector

2:15 p.m.-2:45 p.m. - Spotlight on India and Efforts to Promote the use of International Standards, Abby Prat, Advamed; Leslie McDermont, ANSI; Scott Colburn, FDA/CDRH

2:45 p.m.-3:15 p.m. - Panel Discussion - Challenges to International Harmonization of Medical Device Standards and Regulations


Wednesday, October 20, 2021

10:30 a.m.-11:00 a.m. - Closing Keynote - Consumer Facing Health AI: Ensuring the Safety and Effectiveness of Personal Health Devices and Technologies, Dr. Jesse M. Ehrenfeld, MD, MPH, AMA Board of Trustees, Medical College of Wisconsin 


11:00 a.m.-11:45 a.m. - UDIs Requirements and Opportunities for Global Harmonization, Lena Cordie, Qualitas Professional Services

11:45 a.m.-12:15 p.m. - Standards and Regulation for Combination Products, Jon Cammak, Nevakar; John Weiner, FDA

12:15 p.m.-1:00 p.m. - Cybersecurity Update - Managing Medical Device Cybersecurity in an Increasing Complex and Hostile Environment, Michael McNeal, McKesson; Michelle Jump, MedSec

1:00 p.m.-1:45 p.m. - Virtual Networking Break

1:45 p.m.-2:30 p.m. - Cloud Computing for Medical Devices and Medical Device Quality Systems, Randy Horton, Orthogonel; Pat Baird, Philips

2:30 p.m.-3:15 p.m. - Artificial Intelligence - Developing standards and requirements for artificial intelligence and algorithm change protocols, Pat Baird, Philips; Rob Turpin, BSI

3:15 p.m.-3:30 p.m. - Closing Remarks



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