Hardware Podcasts

Navigating the Twists and Turns of Change Management for Medical Devices

Global Medical Device Podcast · 28 Dec 2019 · 49m · Episode 130

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to discuss change management in the medical device industry, emphasizing that companies must perform engineering and biological analysis before deciding whether to notify the FDA or document a 'letter to file.' Drues argues that many firms incorrectly prioritize regulatory notification over safety impact, stifling innovation, and illustrates this with examples involving catheter logo placement and material substitutions. The conversation highlights the risks of 'change creep' and proposes a pragmatic solution for updating the FDA on multiple minor changes.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Also
FDA, 510(k), PMA, Special 510(k), ISO 13485, EU MDR

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