Hardware Podcasts

What is Regulatory Due Diligence for Medical Devices?

Global Medical Device Podcast · 24 Jun 2020 · 41m · Episode 152

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to define regulatory due diligence as the process of analyzing existing devices and technologies to inform business, regulatory, and engineering decisions before investing resources. Drues distinguishes this from regulatory strategy and pathway, explaining how due diligence applies to both existing products for change management and novel devices by decoupling new technologies into known components. The conversation highlights the importance of integrating regulatory and quality due diligence into the total product lifecycle rather than treating them as static, one-time events.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru
Also
FDA, 510 K, De Novo, PMA

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