Georg Digel
Founder and Owner @Elevate Capa
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WORK HISTORY
Founder and Owner @Elevate Capa
I help quality managers, directors, and VPs of medical device companies strengthen their NC and CAPA processes, enabling them to reduce repeat issues, close investigations faster, and stay audit-ready.Without adding unnecessary complexity or hiring more people.If you’d like to improve:Your NC process → Clearer distinction for when to do correction only vs. initiating a CAPAYour CAPA process → stronger root cause analysis, robust effectiveness criteriaYour audit readiness → compliant, consistent, and defensible recordsThen let\'s connect and chat.So far, I\'ve helped- A quality director to reduce the number of CAPAs through process redesigns (200 employees)- A lead of QA/RA to have 0 findings in external audit after an NC/CAPA process update (100 employees)- Another lead of QA/RA set up meaningful KPIs and train the organization (50 employees)- The QA lead of a start-up to spot and remove regulatory gaps in their procedures (10 employees)
EDUCATION
University of Cooperative Education Bautzen
Dipl.-Ing. (BA), Biomedizintechnik/Medizintechnik
ABOUT GEORG DIGEL
Most quality leaders in medical device companies struggle with recurring NCs, failing CAPAs, and constant overload.Findings on NC & CAPA systems dominate every year (483s, Warning Letters, and Notified Bodies reports).Processes are too complex, timelines drag, and ownership sits only with QA.Each review reveals that CAPAs are opened for minor issues or lack clarity about what issue is solved. On top:1. Investigations miss root causes, and effectiveness fails2. Records are neglected, and actions are overdue3. Metrics are red, and leadership is frustratedThis means you as the person responsible for quality get all the pressure.Imagine a CAPA system that actually works. One that spots issues early, runs smoothly, and earns confidence from auditors and leadership alike.I help quality managers, directors, and VPs redesign their NC & CAPA systems- simplifying processes- strengthening root cause analysis, and- building effective governance.I focus on practical fixes that fit your reality, not theoretical frameworks.Let’s make your CAPA system your strongest asset. not your biggest headache.Things I do with my clients- Train their organization so investigations identify root causes, not symptoms- Simplify procedures so CAPAs are initiated for high-risk issues, not minor problems- Analyze process health and propose a realistic improvement plan (+ help you with implementation)Some results (check below for more)- Created dashboards that manage 500+ open records and visualize each status and risk in seconds- Trained 400+ people on NC/CAPA execution that led to stopping \'human error\' as the root cause- Redesigned procedures to stop opening CAPA for trivial, no-risk matters (reduced # of CAPA by 30%)If you\'re a quality leader in the medical devices industry (ISO 13485) looking to remove complexity from your processes, book a call with me or send me a message.
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