Hardware Podcasts

Auditing the Auditor

Global Medical Device Podcast · 7 Jan 2023 · 41m · Episode 298

What this episode covers

Sara Adams, a Medical Device Guru at Greenlight Guru, explains the nuances of conducting and receiving audits, distinguishing between internal, supplier, notified body, and FDA inspections. She shares her experience managing approximately 25 audits annually at a previous contract manufacturing role and details how to negotiate findings by asking auditors to cite specific regulations. Adams emphasizes building a culture of quality where audits are viewed as opportunities for improvement rather than punitive checks, warning against treating quality management systems as static 'checkbox' exercises.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, BSI, ASQ
Also
Sara Adams, Etienne Nichols, FDA, ISO 13485, CDRH, Seaber, EQMS, Greenlight Guru Academy, MedTech Excellence Community

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