Hardware Podcasts

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Global Medical Device Podcast · 23 Dec 2020 · 42m · Episode 173

What this episode covers

Steven Niedelman and Eric Henry from King & Spalding discuss post-pandemic readiness for the medical device industry, focusing on the transition from Emergency Use Authorizations (EUAs) to full regulatory compliance. They explain the current state of FDA inspections, the role of the Medical Device Single Audit Program (MDSAP), and the critical need for companies to build or remediate Quality Management Systems (QMS) before EUAs are revoked. The guests advise on preparing for pre-submission meetings with the FDA and managing the logistical challenges of a massive influx of regulatory submissions.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
King & Spalding, FDA, Green Light Guru
Also
MDSAP, 21 CFR Part 820, ISO 13485, EU MDR, 510(k), PMA

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