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Hogan Lovells and Dohmen Life Science Services Medical Device Seminar

19 February 20158:30 AM - 5:00 PM (PST) Menlo Park

The seminar will take place on February 19, 2015 from 8:30 a.m. to 5:00 p.m. at Hogan Lovells' Silicon Valley office. Breakfast and lunch will be provided, ending with a cocktail reception.

Topics will include:

  • impact of changing regulatory pathways for new and modified devices, including evolution of the de novo pathway, new issues with establishing substantial equivalence, and recent PMA initiatives such as the parallel review program;
  • panel discussion of recent experiences by industry with the FDA clearance/approval process;
  • new test paradigms for satisfying FDA requirements;
  • FDA's evolving thinking on healthIT and mobile health;
  • considerations for incorporating new technologies such as 3D printing;
  • updates from the compliance front, including responding to warning letters, handling inspections, evaluating recall and MDR reporting policies; and
  • tales of success – lessons learned from bringing innovative technologies to market

Hogan Lovells
Golden Gate Conference Center
4085 Campbell Ave.
Menlo Park

19 February 2015
8:30 AM - 5:00 PM (PST)

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