FDA Trends: Inspections and Submissions
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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.
- 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
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