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Now in its 14th year, FDAnews' Medical Device Quality Congress (MDQC) has become the indisputable must-attend annual event for medical device and diagnostics professionals. Once again for 2017, the co-chairpersons — Steven Niedelmen, and Elaine Messa — have crafted a groundbreaking three-day agenda that will provide attendees with a thorough overview of the key issues confronting devicemakers today.

FALLS CHURCH VA USA – Jan. 10, 2017

14th Annual Medical Device Quality Congress:
Building a Culture to Succeed

**Presented by FDAnews**

March 28-30, 2017 – Bethesda, MD

In all FDAnews’ years serving the medical device community, there has never been uncertainty like that sees today.       

It starts at the very top, with a White House famed for unpredictability, and trickles down into every corner of the FDA and every executive suite.

Call it the Age of Uncertainty for devicemakers.

Everything manufacturers do in 2017 products and processes, relations with regulators, prosperity and problems all will be shaped by Washington. In the Age of Uncertainty, this city holds the key to your very survival.

Mark the calendar for Tuesday-Thursday, March 28-30, 2017 and the 14th Annual Medical Device Quality Congress, sponsored by FDAnews. This is where survival begins.

Meet movers and shakers, rule-makers and rule-breakers. They’re the people who’ll shape the year for better — or worse. Over two full days, they’ll be gathered in a single room at the Medical Device Quality Congress, ready to talk.

Looking for the inside scoop at CDRH? From the new national evaluation system, to the new landscape of auditing, to new initiatives on partnering with patients, every top CDRH leader has been invited to address the Medical Device Quality Congress.

Worried about inspections? The Medical Device Quality Congress features a “mock inspection” where participants role-play the thorny issues you face. Then follow up with a freewheeling audience post-mortem where lingering questions find answers.

The Medical Device Quality Congress comes along once, and only once, a year. At no other time in 2017 will manufacturers have this golden opportunity to:

  • Hear what the Trump Administration, just 88 days in, has planned for the FDA
  • Hear top FDA officials lay out agency plans and objectives, then break bread with these same officials — or even lift a glass — in relaxed social settings
  • Learn from top industry experts, consultants and lawyers, folks who’ve paved the way for better FDA relations and greater success in manufacturing and marketing
  • Hear “war stories” — case studies where manufacturers spotted compliance problems before they turned into disasters, and then discovered no-hassle fixes

Over two full days of Medical Device Quality Congress sessions, attendees will get up to speed on CDRH’s top strategic priorities for 2017 — the national evaluation system, partnering with patients, and the culture of quality initiative — plus dig deep into the following topics:

  • The Critical to Quality (CtQ) initiative
  • Benefit-and-risk analysis of compliance and enforcement actions, including factors the FDA will use in considering post-market actions
  • The Mock Device Inspection featuring role-playing FDA inspectors, quality and regulatory affairs officers, in-house and outside counsel, followed by audience Q&A
  • Update on the Medical Device Single Audit Program Pilot (MSDAP), featuring what to expect from your next audit and what procedures will apply to multiple-site audits
  • European medical device regulations — what to do today, what to expect tomorrow
  • China medical device regulations with special focus on new GMPs, licensing, regulation of contract manufacturers, inspections and self-inspections
  • Update on MedAccred, the Performance Review Institute initiative designed to help you qualify each critical process in the supply chain
  • Software as a medical device — how the FDA is handling cybersecurity and risk management in an area of growing complexity
  • When to submit a 510(k) Premarket Notification — what the draft guidance says and doesn’t say

The following FDA officials have confirmed they will be speaking at MDQC:

  • Robin Newman, Director, Office of Compliance, CDRH, FDA
  • William MacFarland, Director, Division of Enforcement, Office of Compliance, CDRH, FDA
  • Ann Ferriter, Director, Division of Analysis and Program Operations, OC, CDRH, FDA
  • Marc-Henri Winter, Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA
  • Seth Carmody, Staff Fellow, Office of the Center Director CDRH, FDA

The co-chairs, Steven Niedelman Esq. and Elaine Messa, are former top FDA officials as well. Mr. Niedelman was Chief Operating Officer, FDA ORA, and Ms. Messa headed the Los Angeles District, responsible for the largest import operations in the U.S.

Bonus Pre-Conference Morning Workshop

Arrive Tuesday morning and attend the special Pre-Conference Workshop, FDA Cybersecurity and Risk for Devices: From Software as a Device to Ransomware. From 2011, when Barnaby Jack demonstrated how easy it was to hack insulin pumps and pacemakers, hackers have treated medical devices as target-rich environments. Now the FDA is rushing to fill the void, with guidance documents targeting pre-market and post-market cybersecurity.

Expert consultants John Avellanet of Cerulean Associates and Dan O’Leary of Ombu Enterprises are the instructors and guides in this rapidly evolving area. In less than four hours, attendees will learn what they need to know to design and implement their own device cybersecurity program.

Bonus Post-Conference Workshop

Stay one more day and benefit from a special Post-Conference Workshop, Managing & Auditing Medical Device Supplier Quality. Auditing for quality has grown in complexity with the advent of extended supply chains. This morning-long session trains attendees in practical methods for compliant and cost-effective audits.

Expert consultants John Avellanet of Cerulean Associates and Dan O’Leary of Ombu Enterprises understand the issues and their solutions. They’ll introduce tools and techniques that ensure a clean bill of health from regulators foreign and domestic.

Conference Details:

14th Annual Medical Device Quality Congress:
Building a Culture to Succeed

**Presented by FDAnews**

March 28-30, 2017 – Bethesda, MD


Early Bird Registration (until Feb. 17, 2017):

  • Congress Only $1,447
  • Enhanced Congress $1,697 – includes pre-conference workshop
  • Complete Congress $2,547 – includes pre-conference workshop and post-conference supplier controls and management training session

Additional pricing options are available online.

Easy Ways to Register:


By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.