15th Annual Medical Device Quality Congress


8:00 a.m. – 8:45 a.m.

Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Co-chair Elaine Messa, President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA

9:00 a.m. – 9:45 a.m.

Voluntary Medical Device Manufacturing and Product Quality Program

Should you participate in the Voluntary MD Manufacturing and Product Quality Program? Captain Sean Boyd from the FDA will explain the program’s features and why he thinks medical device firms can really benefit themselves by helping move the conversation away from compliance to how well the quality system is delivering value to customers and business.

CAPT Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA (invited)

9:45 a.m. – 10:30 a.m.

Keeping Your Quality System Trim: Lean Principles for GMPs

Some of the most successful medical device manufacturers are using the Lean Principles it to improve their bottom line while ensuring quality. You may already be using some of these principles but just have not heard of the names before, such ask “kanban, heijunka and muda.” In this session, you’ll learn how to use lean management principles to increase quality, reduce waste (and costs), and increase output – all without losing sight of your compliance responsibilities.

James Shore, President, Quality Lean Solutions

10:30 a.m. – 10:45 a.m.

Refreshment Break

10:45 a.m. – 12:15 p.m.

Panel Discussion: European Medical Device Regulations — Preparing for the Storm

Like a line of thunderstorms developed on a weather front, various regulatory agencies will move through your company to check up on the Quality Management System. Each visit will be different because they will look at different aspects. The FDA will check your adherence to US regulations. The MDSAP will help prepare you for Canada, Australia, Brazil and other jurisdictions in the program. The unknown factor is the status of the MDR Notified Bodies (NB). There aren’t any yet, as the regulation moves through its transition process. We do know that qualifying NBs will conduct audits that are more rigorous than under the directives. The MDR Annex VII, Section 4.5. Conformity Assessment Activities, lists specific requirements for the NB to cover during an audit.

This expert panel will take you through the changes and what you need to know to be prepared to continue to market or bring your product to market in Europe.


Maria Fagan, President, Regulatory and Quality Solutions (R&Q)


  • Robert Ruff, Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA
  • Dan O’Leary, President, Ombu Enterprises LLC
  • Karl Vahey, Vice President Manufacturing Quality, Cardinal Health
  • Ibim Tariah, Technical Director, BSI Americas Inc. (invited)

12:15 p.m. – 1:15 p.m.


1:15 p.m. – 2:00 p.m.

Meet NEST: Building a National Medical Device Surveillance System

FDA has been working since 2014 to build a sustainable national system to evaluate the risks and benefits of medical devices. Enter the National Evaluation System for health Technology (NEST) with a mission to “support optimal patient care by leveraging the experiences of patients to inform decisions about medical device safety, effectiveness, and quality in order to promote the public health.” In this session, FDA Associate Director for National Devices Surveillance Gregory Pappas outlines the program’s evolution and goals, and presents opportunities for devicemakers to get involved in the data-sharing initiative.

Gregory Pappas, M.D., Ph.D., Associate Director for National Devices Surveillance, Office of Surveillance and Biometrics, CDRH, FDA (invited)

2:00 p.m. – 2:45 p.m.

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

Software has become a critical part of medical devices. More and more medical devices have software embedded or interface with another device or healthcare system that has software as an integral part. Given the increased complexity of medical device software, best practices in risk management and cybersecurity are critical and challenging.

Attendees will learn:

  • What the FDA’s latest initiatives on device software risk management and cybersecurity are
  • How a device manufacturer overcomes technical as well as regulatory compliance challenges
  • What resources and tools are available
  • What the industry’s best practices are

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

2:45 p.m. – 3:00 p.m.

Refreshment Break

3:00 p.m. – 4:30 p.m.

Panel Discussion: MEDDEV 2.7/1 revision 4 and Clinical Evaluation Reporting (CER)

From frequency of reports to specific requirements for authors and evaluators, the fourth revision of MEDDEV 2.7.1 provides more explicit guidance on conducting and reporting on clinical evaluations. It is critical that manufacturers understand the requirements to gain market access to countries relying on the CE Mark. Key takeaways from this session include strategies for literature evaluation, scoping “the right” research questions and perspectives on leveraging data from equivalent competitive products.


Carol Ryerson, Sr. Principal Advisor, Regulator Affairs, RCRI


  • Lisa Casavant, Founder, VP, Regulatory and Quality Solutions (R&Q)
  • Stephan Buttron, Principal Medical Research Manager of Regulatory Affairs at NAMSA (invited)
  • Ruthanne Vendy, Principal Specialist, Regulatory and Quality Solutions (R&Q) (invited)
  • Anne Le Rouzo, West Coast Regional Director & Certification Project Manager/Lead Auditor, LNE/G-MED North America, Inc. (invited)

4:30 p.m.

Closing Comments by Co-chairs Steven Niedelman and Elaine Messa



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