Georg Digel
Helping medical device quality teams to identify root causes, close NCs and CAPAs on time effectively, bring metrics back to green & pass audits with confidence. Sign up for my free newsletter, where I share breakdowns of what is working and what's not to keep your NC&CAPA system healthy.
Welcome to my page! Happy to have you here.
I'm a former:
- principal NC&CAPA quality engineer
- strategic quality project lead
- consultant
- pizza delivery driver
I was responsible for ISO 13485 quality management system certifications, led NC&CAPA and overall quality improvement initiatives. I also had to defend all of that in Notified Body audits + FDA investigations ... so no worries - I know what it feels like to be challenged.
Since September 2025, I support medical device quality teams to bring their NC&CAPA performance to the next level.
My clients usually struggle with:
- Raising every minor issue as CAPA, because they don't know how to evaluate internal & external signals
- Not understanding how to mitigate regulatory gaps in their procedures
- Separating symptoms from true root causes in investigations
- Coming up with meaningful (and reasonable) actions plans
- Proving that the actions were effective in tackling root causes
- Keepin oversight over their overall metrics and progress
If you have similar issues within your company and you're a quality manager, director, head of QARA or VP of a medical device companies, then feel free to book a free strategy call.
We will do a quick analysis of where you are and what holds you back before we draft a tailored improvement strategy.
Looking forward to speaking to you,
Georg