Live! #8 — FDA Trends: Inspections and Submissions

This is the audio-only version of RQM+ Live! #8, originally recorded June 4th, 2020.

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

Moderator:

Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q

R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.

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