Hardware Podcasts

Best Practices for Implementing Design Controls for the Medical Device Industry

Global Medical Device Podcast · 7 Nov 2019 · 26m · Episode 1

What this episode covers

Host Bill Loth interviews Mike Drues, President of Vascular Sciences, and Jon Speer, Co-founder of greenlight.guru, about implementing design controls in the medical device industry. The guests argue that design controls should begin at project initiation as 'prudent engineering' rather than waiting for regulatory mandates, helping startups maximize their attractiveness to acquirers. They discuss the risks of ignoring documentation for early funding milestones like the 510(k) and how to manage the transition when a device's classification changes from Class I to Class II or III.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
greenlight.guru, Vascular Sciences
Also
FDA, 510 K, ISO

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