Hardware Podcasts

Understanding the 'Compliance Manager' Role

Global Medical Device Podcast · 9 Mar 2023 · 21m · Episode 309

What this episode covers

Maryann Mitchell, a Solutions Engineer at Greenlight Guru with 15 years of medical device experience, explains the role of a Compliance Manager and the cultural barriers between engineering and quality teams. She details challenges in managing multi-site quality systems, such as right-sizing procedures for sites ranging from 11 to 1,000 employees, and the pain of losing traceability when engineers iterate without documentation. Mitchell contrasts paper-based systems with electronic Quality Management Systems (eQMS), highlighting how eQMS improves audit defense and reduces administrative bottlenecks like lost physical documents.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru
Also
Maryann Mitchell, Etienne Nichols, MedTech Excellence, FDA, Notified Body, eQMS, SharePoint, Google, Dropbox, DocuSign

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