Annual Medical Device Quality Congress Presentations

MDQC 2017
Click on the presentation title to view the presentation
 
Tuesday, March 28, 2017PRE-CONFERENCE WORKSHOP

8:30 a.m. – 12:00 p.m.

FDA Cybersecurity and Risk for Devices – from Software as a Device to Ransomware

Expert Instructors:
John Avellanet, Managing Director & Principal, Cerulean Associates LLC
Dan O’Leary, President, Ombu Enterprises LLC

 

Tuesday, March 28, 2017DAY 1

1:15 p.m. – 2:00 p.m.

Update from the Office of Compliance at CDRH: Priorities and Strategies for 2017

Robin Newman, Director, Office of Compliance, CDRH, FDA

2:00 p.m. – 2: 45 p.m.

Enacting the Case for Quality: Defining Metrics

William MacFarland, Director, Division of Enforcement, Office of Compliance, CDRH, FDA

3:00 p.m. – 4:15 p.m.

Benefit–Risk Considerations for Medical Devices: Panel Discussion

Moderator:

Beverly Lorell, M.D., Senior Medical and Policy Advisor, King and Spalding

Panelists:

  • Robin Newman, Director, Office of Compliance, CDRH, FDA
  • Ann Ferriter, Director, Division of Analysis and Program Operations, OC, CDRH, FDA
  • Nikki Willet, Director Strategy, Medical Device & Diagnostics Industry, Veeva Systems

4:15 p.m. – 5:15 p.m.

Product Liability and Your Supply Chain

Courtney Stevens, Senior Attorney, Risk Management, MedMarc Insurance Group

 

Wednesday, March 29, 2017DAY 2

8:45 a.m. – 9:30 a.m.

Medical Device Single Audit Program Pilot (MDSAP) Update

Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA

9:30 a.m. – 10:15 a.m.

The 21st Century Cures Act’s Impact on Medical Devices

Michael Gaba, Partner, Holland & Knight

10:30 a.m. – 12:00 p.m.

European Medical Device Regulations — What To Expect: Panel Discussion

Dan O’Leary, President, Ombu Enterprises LLC
Ibim Tariah, Technical Director, BSI Americas Inc.

1:00 p.m. – 1:45 p.m.

MedAccred Update: Devicemakers Driving Quality Standards for Their Suppliers

Connie Conboy, Director, Strategy & Business Development, Performance Review Institute
Scott Dauphinee, Director Supplier Quality, Johnson & Johnson
Julia Markardt, Staff Engineer - Electronics, Performance Review Institute
Ravi Nabar, Industry Expert

1:45 p.m. – 2:30 p.m.

FDA’s Focus on Risk Management and Cybersecurity for Devices that Contain Software

Seth Carmody, Staff Fellow, Office of the Center Director, CDRH, FDA

2:45 p.m. – 3:45 p.m.

Prospects for the FDA Under the Trump Administration: The Latest News from Washington

Steven Grossman, President, HPS Group, LLC

3:45 p.m. – 4:30 p.m.

China CFDA Medical Device Pre-Market Approval and Post Market Quality Regulatory System Overview

Grace Fu Palma, Founder, China Med Device

 

Thursday, March 30, 2017

8:30 a.m. – 5:30 p.m.

Managing & Auditing Medical Device Supplier Quality

Supporting Materials

Expert Instructors:
John Avellanet, Managing Director & Principal, Cerulean Associates LLC
Dan O’Leary, President, Ombu Enterprises LLC