16th Annual Medical Device Quality Congress

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Medical devicemakers are convening April 23-25 in Washington for the regulatory event of the year:

16th Annual Medical Device Quality Congress

This year’s theme: “Device Regulation Undergoes a Sea Change.” And sea change it is …

Technology. Data. Medical discoveries. Patient pressure. Public-private partnerships. And possibly most important of all, the sea change in regulatory philosophy exemplified by FDA Chief Dr. Scott Gottlieb, Donald Trump’s hand-picked FDA chief. Under Gottlieb, the agency has sent quality regulation back to the drawing board.

  • The very definition of ‘medical device’ is under scrutiny
  • CDRH is up for reorganization
  • The pre-market submission process is being liberalized
  • Even as post-market surveillance sees new restrictions imposed
  • Digital is getting fast-tracked
  • The agency is adapting to the data revolution
  • Giving device remanufacturing new scrutiny
  • And pushing the Program Alignment Plan
  • Public-private partnerships are sprouting
  • The agency is adapting to the data revolution
  • Device remanufacturing gets new scrutiny
  • And much more!

It’s all big-picture stuff you need to know. The Medical Device Quality Congress gets into the weeds, too, with timely assistance on quality audits, cybersecurity, product recalls and more.

Add on the half-day Pre-Conference Workshop on Correction and Corrective Action and start off “Congress Week” with a bang.

And for more of the Big Picture, stick around Thursday for the full-day Post-Conference Workshop, “Post-Market Activities in the EU-MDR”.

Full Agendas: Main Conference, Pre- and Post-Conference Workshops

You’ll learn from the best. Conference chair Steven Niedelman Esq., now in private practice, used to serve as Chief Operating Officer, FDA ORA. He heads an all-star list of top agency officials, speaking candidly on regulatory dilemmas even as they dish on regulatory plans … the cream of the Washington FDA bar, doling out free legal advice worth tens of thousands of dollars … experts from the private sector, sharing latest innovations … consultants with deep technical expertise, untangling knotty problems.

Full Roster of Confirmed and Invited Speakers

This year we’ve selected the Bethesda Marriott North Hotel & Conference Center for our venue. Its location is ideal — halfway between FDA headquarters and the bustle of the nation’s capital. Spring is Washington’s finest season, a time to enjoy balmy weather and bursts of spring color as you sample the delights of one of America’s favorite tourist destinations. Why not plan on making a weekend of it?

Whatever you do though, be sure to mark your calendar for April 23-25. Even if you attend nothing else during 2019, the 16th Annual Medical Device Quality Congress is the one you dare not miss.