Hardware Podcasts

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Global Medical Device Podcast · 8 Sept 2021 · 28m · Episode 227

What this episode covers

Christie Johnson, founder of Kasota Engineering, joins host Jon Speer to discuss quality management system (QMS) strategies for early-stage medical device startups. Johnson advocates for a 'teach mentality' over hiring senior QA veterans, arguing that researchers and engineers can be coached to build simple, usable quality systems from scratch. She critiques traditional consulting models that deliver static SOPs and emphasizes documenting the product development story to preserve tribal knowledge and reduce risk.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Kasota Engineering, Greenlight Guru, Prodct
Also
RADx, ISO 13485, FDA

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