Hardware Podcasts

Developing a Regulatory Strategy

Global Medical Device Podcast · 23 Nov 2022 · 43m · Episode 291

What this episode covers

Mike Drues, President of Vascular Sciences, explains to host John Speer that a regulatory strategy is a dynamic plan of action, not merely a submission pathway like 510(k) or PMA. Drues emphasizes the importance of integrating international regulatory requirements early to avoid costly re-testing and highlights the critical need to align regulatory strategy with reimbursement strategy, using CMS as a key example. He argues that the EU MDR primarily impacts administrative processes rather than engineering testing, while stressing that post-market surveillance remains an industry-wide failure that requires proactive management.

Most relevant to

early-stage companies

Topics

Mentioned

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

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