Hardware Podcasts

#370: Meet a Guru: Jamie Bihary

Global Medical Device Podcast · 30 May 2024 · 32m · Episode 370

What this episode covers

Jamie Bihary, a Medical Device Guru at Greenlight Guru, explains her transition from biomedical engineering to helping companies migrate from legacy Quality Management Systems (QMS) to electronic QMS (EQMS). She details the challenges of document migration, emphasizing the importance of clean room environmental monitoring to prevent endotoxin contamination and the value of internal audits in maintaining compliance. Bihary highlights Greenlight Guru’s partner network and support systems, advising startups to leverage consultants and realistic planning to navigate the complexities of QMS implementation.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, BSI, ISO 13485

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