Hardware Podcasts

Meet a Guru: Brittani Smith

Global Medical Device Podcast · 20 Apr 2023 · 29m · Episode 315

What this episode covers

Brittani Smith, a Medical Device Guru at Greenlight Guru, discusses her rapid career progression from regulatory coordinator to development engineering in just over two years. She emphasizes the importance of reading primary standards like ISO 13485 and 14971 to build confidence and avoid pitfalls in UDI and EU MDR implementation. Smith highlights the critical need for comprehensive documentation to prevent reliance on tribal knowledge and advises medical device professionals to assess risk and quality processes early in the design phase.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, BSI
Also
ISO 13485, ISO 14971, EU MDR, UDI

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