Work with me
Start small: one focused hour on your hardest CAPA, procedure, or question — booked and paid in two minutes. Or go deep: book me for an outside review of where your whole system actually stands.
Start small
Bring whatever is burning: a CAPA that won’t close, a root cause you don’t believe, a procedure that’s grown too heavy, an investigation you’d rather not defend alone — or open questions before an audit. We work through it together, live.
€199 · 60 minutes · video call
You can pick your slot after payment.
Secure payment via Stripe. Schedule immediately after.
“He came well-prepared, having taken the time to read about our company and understand what we do, something I don’t often experience from consultants. After a brief review of our process documents, he was able to pinpoint several gaps that were preventing us from having a streamlined procedure for NC and CAPA management. His explanations were clear, thorough, and pedagogical, which made it easy to understand how we could efficiently close those gaps.
I highly recommend seeking advice from elevateCAPA if you are a smaller business like ours looking to improve your NC-CAPA management, an area that is often misunderstood and difficult to get right.”
Maria S. — QA Manager
Go deep
You can feel something’s off. Investigations that blame “human error”. CAPAs closed “effective” after yet another retraining. The feeling that if an auditor pulled five records at random, four would be insufficient.
The Clarity Assessment is an outside review of where your system genuinely stands — from someone who’s sat in your chair. The belief under all of it: not every problem needs the same level of treatment. The skill is choosing which NC stops after correction, which continues with CA and PA — and being able to defend the choice.
A written NC/CAPA Clarity Report, plus a debrief call where I walk you through it:
Something you can present to management and start implementing the next day.
Starts at €3.000 · no hourly billing
We confirm the exact problem scope on a short call and I present how we could work together, so you know exactly what you’re committing to before you do.
A short call to confirm fit, scope and budget. No obligation to buy, but please don’t book a call if you’re not planning to invest right now. Let’s be mindful of each other’s time.
I spent a decade+ inside medical device companies in global quality roles. I've been responsible for the NC&CAPA performance of 25+ sites, moved on to build and monitor training programs for our global workforce and later I was part of a multi-million FDA remediation.
I know what an auditor looks for, what a real finding costs, and the difference between a record that looks closed and a system that’s actually under control.
“I had the privilege of working with Georg Digel for two years while he designed the global CAPA process for our multinational corporation. Georg’s exceptional strength lies in his ability to translate complex regulatory requirements — ISO 13485, MDD, and FDA — into workable, globally harmonized processes. Particularly impressive was his intercultural competence: he masterfully integrated differing regional approaches into one coherent, compliant system.
The quality of his work was confirmed by our corporation’s Global Quality Award. I recommend Georg without reservation to any company that needs robust, internationally scalable quality management systems.”
Ronald W. — Chief Quality Officer
Abdu Samad — Head of Regulatory Affairs & Quality Assurance
Faizan Javed — QARA Leader
I won’t promise you a clean audit, zero findings, or a guarantee. Nobody honest can.
What I promise is the truth about where you stand and a clear order of what to deal with first. That’s the whole point: clarity, not a quick fix.
Not sure which one? Start with the Clinic — if a deeper review makes sense, we’ll both know it after that hour.
The payment confirmation page shows my scheduling link — pick any open slot that suits you. Of course you’ll also receive an invoice.
Whatever you want a second pair of eyes on: a CAPA record, an investigation, a procedure, your NC workflow — or just questions. One case works best; we go deep rather than wide.
It starts from €3.000, but depends on what challenges you try to tackle and how much of my support you want. No hourly billing, no scope creep. We confirm the exact scope and fee on the call so there are no surprises.
The assessment delivers clarity and a prioritised plan, not the fix itself. Many teams act on the report internally. If you want help implementing afterwards, we can discuss that separately.
That’s rather the point. You’re paying for the truth while you can still act on it, not for reassurance that everything’s fine.
Limited. I need access to your procedures, your eQMS setup, and a sample of records, plus a couple of short conversations. The heavy lifting is mine.
Yes — both the Clinic and the assessment. Everything stays between us, under appropriate confidentiality.
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