DEVICE L❤️VE Live! #8 — June 4, 2020

Upcoming and on-demand education, commentary from thought leaders, Q&A features, and more.


 In the midst of the coronavirus pandemic and reduced travel/networking, please remember this page offers the latest virtual education, training, and industry information from R&Q. 

FDA Trends: Inspections and Submissions

--- DEVICE L❤️VE Live! is a weekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. Please view our blog for a other shows, along with other R&Q events and learning opportunities. ---

 

RQ_Device_Love_Live_8-min

With the EU being on the hot seat lately, and all eyes and discussions on the MDR, you might be left wondering...

 

— What's the latest in FDA trends?

 

— Is FDA going harder or lighter on inspections?

 

— Are 510(k) submissions being scrutinized more than ever – in line with the pendulum swing of the European Commission – or is it status quo for the FDA?

 

R&Q experts will share what we're seeing across a multitude of device companies with varying clinical specialties and geographies. Attendees should expect to get a glimpse of what to expect! We're looking forward to this one and hope you'll join us.

The panel will include:

  • Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Counsel, R&Q
  • Jake O'Donnell — Senior FDA Compliance Principal, R&Q (former FDA)
  • Kevin Go — Senior Engineer (former FDA)
  • Jessica Andreshak, CQA, RAC GS — Senior Principal Specialist, R&Q

We encourage you to come with questions! Our panel will be ready.

Sign up below.