Direct from the FDA: Top Five Tips for Medical Device Companies

Given market changes and recent 510(k) reform efforts, there is much confusion regarding the FDA's expectations for medical device companies.

Join us for a direct conversation with the agency covering topics including:

  • The evolution of the 510(k) program
  • FDA's approach to compliance programs including inspections, recalls, warning letters and more
  • Tips for medical device companies at all stages
Speakers
Mutahar Shamsi District Director, FDA New England District Office
Mark Heller Partner and Chair of FDA Practice, Goodwin Procter LLP
Ray Zemlin Partner, Goodwin Procter LLP

Wednesday, June 15, 2011

8:30 - 9:00 am Breakfast
9:00 - 10:00 am Program
10:00 - 10:30 am Open Q&A

Goodwin Procter Conference Center
Exchange Place, Boston

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Contact us if you have questions regarding this event.

www.goodwinprocter.com