Hardware Podcasts

Leaning into Lean Documentation

Global Medical Device Podcast · 7 Jun 2023 · 55m · Episode 322

What this episode covers

Steve Gompertz, a partner at QRX Partners with experience at St. Jude Medical, Boston Scientific, and Medtronic, explains the concept of lean documentation in medical device Quality Management Systems (QMS). He argues that documentation should be written for employees, not auditors, using hierarchical structures like flowcharts and appendices to improve usability. Gompertz details how to build effective Standard Operating Procedures (SOPs), manage CAPA execution, and prove the ROI of a well-architected QMS by reducing audit findings. He also outlines the essential early-stage components for a new medical device company, emphasizing design controls and management responsibility.

Most relevant to

early-stage companies, companies scaling up and large enterprises

Topics

Mentioned

Companies
QRX Partners, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, Control Data, Greenlight Guru
Also
ISO 13485, ISO 14971, FDA, BSI, G2

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