Hardware Podcasts

#360: Is It Possible to "Buy" a QMS?

Global Medical Device Podcast · 11 Apr 2024 · 32m · Episode 360

What this episode covers

Sara Adams, a quality engineering expert with extensive experience in FDA inspections, explains why Quality Management Systems (QMS) cannot be bought off-the-shelf, using a sourdough bread analogy to illustrate the need for customization. She details the layers of a QMS, from procedural documents to electronic storage, emphasizing that while tools like Greenlight Guru provide 'guardrails,' the specific procedures must be tailored to the company's risk profile and regulatory requirements. Adams highlights common pitfalls, such as using non-compliant signatures in SharePoint or paper-based systems, and stresses that the ultimate goal of any QMS decision is patient safety, not just passing an audit.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Cleio
Tools
SharePoint
Also
ISO 13485, FDA

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