Schedule of Events

Tuesday, April

8:30 am–9:30 am

Keynote: Overview of 21st Century Cures Act and Medical Device User Fee Agreement (MDUFA) IV

William Maisel, MD, MPH, Deputy Center Director for Science and CDRH Chief Scientist, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)

9:30 am–10:30 am

Changing role of standards in the regulatory process (21st Century Cures new standards recognition process and MDUFA accreditation scheme for conformity assessment)
Scott Colburn, MS, BSN, RN, Director, CDRH Standards Program, FDA
10:30 am–10:45 am—Coffee Break

10:45 am–11:15 am

Update on the implementation of the UDI rule and international implications
Terrie Reed, FDA Senior Advisor for UDI Adoption

 11:15 am–12:00 noon

Review and discussion of the final FDA rule on Combination Products and the role of standards
Melissa Burns, Policy Advisor, Office of Combination Products, FDA
12:00 noon–1:00 pm—Lunch

1:00 pm–2:45 pm

Moving toward 21st Century Quality Management and Risk Management for Healthcare Technology
  • Update on FDA’s Case for Quality
    Francisco Vicenty, Case for Quality Program Manager (Acting) CDRH/FDA
  • Evolving Quality Management Systems Standards
    Eamonn Hoxey, PhD, BPharm, FRPharmS, Director, E V Hoxey Ltd
  • The futures of risk-based management—Revision of ISO 14971 and beyond
    Pat Baird, Regulatory Affairs Specialist, Philips
  • FDA perspectives on risk
    Erin Keith, Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental, CDRH/FDA

2:45 pm–3:00 pm—Coffee Break

3:00 pm–4:45 pm

Digital Health Update – FDA and Industry Perspectives on Cybersecurity, Medical Device Security, and Health IT
  • Bakul Patel, MSEE, MBA, Associate Director for Digital Health, CDRH/FDA
  • Patricia Krantz-Zuppen, Principal SW Engineer/Standards Advisor, Medtronic
  • Michelle Jump, Regulatory Affairs Associate Analyst, Stryker

Wednesday, April 5

8:30 am–10:15 am

International Medical Device Regulators Forum (IMDRF) Activities

  • Overview of the current work of the IMDRF
    Melissa Torres, Associate Director for International Affairs, CDRH/FDA
  • FDA and BSI experience with the Global Medical Device Single Audit Program
    Patricia Murphy, Global MDSAP Manager, BSI
  • Improving the quality of internationals standards for regulatory use
    Jeff Eggleston, Corporate Standards Advisor, Medtronic
    Gail Rodríguez, PhD, FDA Fellow

10:15 am–10:30 am—Coffee Break

10:30 am–11:15 am

Keynote: The Evolving EU Regulations

John Wilkinson, Director of Devices, Medicines & Healthcare Products Regulatory Agency (MHRA), Government of the United Kingdom

11:15 am–11:45 am

The New MDR: An Overview
Ibim Tariah, Technical Director, BSI

11:45 pm–12:45 pm—Lunch

12:45 pm–1:45 pm

Changes in EU clinical requirements
Ronald Rakos, PHD, Global Head of Vascular, BSI

1:45 pm–2:45 pm

Economic Operators
Eamonn Hoxey, PhD, BPharm, FRPharmS, Director, E V Hoxey Ltd

2:45 pm–3:00 pm—Coffee Break
3:00 pm–3:45 pm

The new IVDR: Significant Changes for the Industry
Stefan Burde, IVD Product Expert, BSI

3:45 pm–4:30 pm

Q&A with the experts on the European MDRs