Hardware Podcasts

How To Improve Your Medical Device Design Reviews

Global Medical Device Podcast · 7 Nov 2019 · 24m · Episode 3

What this episode covers

Michael Drues, Jason McKibbin, and Jon Speer of Greenlight Guru discuss strategies for improving medical device design reviews, emphasizing that they are critical checkpoints within design controls rather than mere regulatory checkboxes. The experts argue for more frequent reviews, the necessity of truly independent reviewers to avoid bias, and the importance of fostering a culture of trust and open dialogue. They highlight that design reviews should address both 'designing the device right' and 'designing the right device' to prevent costly errors and ensure patient safety.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences, Medicis
Also
FDA, ISO, Medical Device Online

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