Hardware Podcasts

Virtual Auditing in a Post-COVID World of Digital Compliance

Global Medical Device Podcast · 18 Feb 2021 · 30m · Episode 180

What this episode covers

Colleen Hittle, founder of ProVeritas Partners, discusses the shift to virtual auditing and compliance in the medical device industry during the pandemic. She explains that while notified bodies adopted remote monitoring early, the FDA was slower to embrace virtual inspections, creating challenges in assessing facility context and human interaction. Hittle outlines practical workarounds, such as using video walkthroughs and pre-recorded process videos, to simulate on-site presence, and argues that virtual audits will likely remain a permanent part of the regulatory toolkit due to cost and talent retention benefits.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
ProVeritas Partners, Green Light guru
Also
FDA, ISO, MDSAP

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