Georg Digel

Georg Digel

📍 Hamburg ISO 13485 · Medical Device QMS

Ex-Corporate principal engineer helping Heads of QA/RA & quality managers fix what’s wrong with their NC & CAPA — before the auditor flags it.

500+ quality professionals read the MedTech CAPA Journal, about twice a week: frameworks to focus on the NCs and CAPAs that matter, keep your system effective without overengineering it, and defend it in your next audit or inspection, plus opinions and a look behind the scenes of my work. Subscribe and I’ll send you the CAPA Stress Test toolkit as a welcome gift.

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Free resources

The CAPA Stress Test, the Triage Tree — practical tools you can use today. No login or purchase required.

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Want to work with me?

Request NC/CAPA training for your team (ISO 13485, QMSR), or get my eyes on your NC/CAPA performance and the plan to improve it.

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Simple NC & CAPA dashboard

For leaders responsible for NC & CAPA performance: which of your open records put patients or your next audit at risk? Click through a sample dashboard and see the eight red flags that pick out the records that need a decision from you.

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“His drive for excellence is unmatched, and his talent lies in simplifying complex concepts for easy understanding… Georg offers an impressive combination — robust soft skills entwined with deep knowledge in CAPA and compliance.”

Marina D. — QA Manager

Georg Digel
Medical Device (ISO 13485) · NCs & CAPAs
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