Hardware Podcasts

Quality Management for IVD Devices vs Medical Devices

Global Medical Device Podcast · 5 Apr 2021 · 41m · Episode 193

What this episode covers

Joanne LeBrun of MDC Associates explains that while In Vitro Diagnostic (IVD) devices share quality management system (QMS) requirements with medical devices, they differ in performance proof, with IVDs often relying on leftover specimens rather than clinical studies. She highlights that the EU IVDR has significantly expanded regulation by changing device classification, while the pandemic has accelerated startup growth through contract manufacturing and molecular science advancements. LeBrun advises startups to avoid starting with a blank QMS, emphasizing the importance of robust internal audits, real-time documentation, and managing FDA inspections to prevent costly field failures and recalls.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
MDC Associates, Greenlight Guru, Abbott Laboratories
Also
EU MDR, IVDR, ISO 13485, FDA

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