Hardware Podcasts

Meet a Guru: Sara Adams

Global Medical Device Podcast · 17 Mar 2021 · 20m · Episode 188

What this episode covers

Sara Adams, a medical device guru at Greenlight Guru, discusses her background as a quality engineer and her experience implementing an electronic Quality Management System (QMS) at a previous employer. She explains the challenges of transitioning from a paper-based system, emphasizing the importance of laying a strong foundation through documents and training to manage employee resistance to change. Adams also highlights the industry shift toward virtual audits during the pandemic and stresses the importance of understanding ISO 13485 and FDA requirements for medical device companies.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
Sara Adams, John Spear, ISO 13485, FDA

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