15th Annual Medical Device Quality Congress


12:00 p.m. – 1:00 p.m.


1:00 p.m. – 1:15 p.m.

Welcome and Introduction by Co-chair Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding LLP; former FDA Deputy Associate Commissioner for Regulatory Operations

1:15 p.m. – 2:00 p.m.

Update from the Office of Compliance at CDRH: Priorities and Strategies for 2018

A can’t-miss session, where William Maisel will discuss CDRH’s top strategic priorities for FY 2018. He will update you on progress made on the 2017 priorities and what is still left to do. He will also touch on some of CDRH’s regulatory science priorities. Some key areas of interest include:

  • Establishing a national evaluation system for medical devices by increasing access and use to real-world evidence to support regulatory decision making
  • Partnering with patients by promoting a culture of meaningful engagement by facilitating CDRH interaction with patients while increasing patient input as part of the decision making.
  • Promoting a culture of quality and organizational excellence
  • A Summary of the Regulatory Science Subcommittee’s assessment of regulatory science needs within CDRH
  • FDA’s program alignment plan

William Maisel, Acting Director, Office of Compliance, CDRH, FDA (invited)


2:00 p.m. – 2:45 p.m.

ISO 13485:2016 – Starting The Final Countdown

Last March, ISO issued the new version of ISO 13485:2016. All existing ISO 13485 certificates must be transitioned to the new version of the standard by February 28, 2019 – when the MDQC conference meets, the deadline will be less than a year away! Failing to meet this deadline can be costly, so it’s in your interest to be ahead of the curve. Device quality expert Robert Ruff will walk you through the best practices to ensure you are on the right track in your transition plan.

Attendees will learn:

  • The transition plan for certificates
  • The transition plan for the EU Harmonized Standard
  • The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it
  • The major differences between ISO 13485:2003 and ISO 13485:2016

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

2:45 p.m. – 3:00 p.m.

Refreshment Break

3:00 p.m. – 4:30 p.m.

Panel Discussion: Enacting the Case for Quality: Defining Metrics

CDRH launched the Critical to Quality (CtQ) initiative to strengthen product and manufacturing quality. The CtQ program is meant to overcome the traditional relationship between FDA and industry that is too focused on managing compliance rather than the shared goal of for continuously improving quality. In this session, you’ll hear about the CtQ initiative and the CtQ information documents that have been published.


Stephanie Christopher, Program Director, CfQ & PCBR, MDIC


  • William MacFarland, Director, Division of Enforcement, Office of Compliance, CDRH, FDA (invited)
  • Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, CDRH, FDA (invited)
  • Al Crouse, Sr. Quality Director, CVRx Inc.

4:30 p.m. – 4:35 p.m.

Refreshment Break

4:35 p.m. – 5:20 p.m.

Preparing for the MDSAP Audit Process: A Case Study from the Manufacturer’s Perspective

Manufacturers entering the Medical Device Single Audit Program undergo an assessment performed by a single third-party inspector that proves compliance in the US, Canada, Australia, Brazil, the EU and Japan. The audit process is not what you’re used to compared to an FDA or ISO audit. Cynosure has successfully certified two manufacturing sites in the last year. The Cynosure facility in MA (1,000 people) was audited as part of the MDSAP in October 2016 and their facility in NY (40 people) was audited to the MDSAP in March 2017. Both facilities passed the audit with only minor findings.

Executive Vice President of RA/QA Connie Hoy will take you through the preparation process from the manufacturing perspective. You will also hear what lessons they learned along the way, what they would have done differently and how it compares to a corporate audit versus a small manufacturing plant audit.

This presentation will cover:

  • What they did to prepare for the audit
  • The audit flow and how it differs from QSIT and ISO audits
  • The differences and similarities between preparing the two plants
  • What they would do differently to prepare now that they have undergone the process.

Connie Hoy, Executive Vice President of RA/QA, Cynosure

5:20 p.m. – 6:30 p.m.

Networking Reception



Pre-conference | Day 1 | Day 2 | Post-conference

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