Hardware Podcasts

S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

Being an Engineer · 19 Jul 2024 · 51m · Episode 29

What this episode covers

Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He details the evolution of regulatory frameworks, noting the shift toward stricter EU standards and the integration of AI and cybersecurity into device compliance. Gompertz emphasizes tailoring quality systems to company size, using a case study of a client who reduced FDA findings from dozens to zero by implementing a holistic, process-connected system rather than a checklist approach. He also advocates for concurrent engineering and cross-functional teams to accelerate development while maintaining rigorous safety standards.

Most relevant to

early-stage companies, companies scaling up and large enterprises

Topics

Mentioned

Companies
QRx Partners, Medtronic, Boston Scientific, St. Jude Medical, Pelican Biothermal, Pipeline Design & Engineering
Also
FDA, ISO 13485

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