Welcome! I'm happy to have you here.
I'm Georg Digel and since September 2025 I've been helping medical device quality teams bring their NC & CAPA performance to the next level.
Who this is for
You're a great fit if you are a…
- Quality Manager
- Quality Director
- Head of QARA
- VP at a medical device company
…and your team is dealing with:
- NC&CAPA process inefficiencies
- Regulatory compliance gaps
- Ineffective root cause investigations
- Lack of quality oversight and metrics
If any of this resonates, a free Gameplan call is the fastest way to get clarity on where you stand and what's holding you back.
My background
I've worn many hats - from pizza delivery driver to principal CAPA quality engineer. Here's what shaped my expertise:
ISO 13485 certification
I've been responsible for ISO 13485 (and 9001) quality management system certifications across organizations.
Strategic quality lead
Led NC&CAPA and overall quality improvement initiatives as a strategic project lead.
External audit & investigation experienced
Defended quality systems in Notified Body audits and FDA investigations … I know what it feels like to be challenged.
Proud father
I have a beautiful family and I know that some things are just out of our control. ;)
Sound familiar? Common struggles I see
My clients — quality managers, directors, heads of QARA, and VPs at medical device companies — typically come to me with one or more of these challenges:
6 NC&CAPA pain points
1
Raising every issue as CAPA
Not knowing how to evaluate internal and external signals leads to CAPA overload.
2
Regulatory gap mitigation
Struggling to understand how to address regulatory gaps in existing procedures after audit findings.
3
Symptoms vs. root causes
Failing to separate surface-level symptoms from the true underlying root causes in investigations.
4
Weak action plans
Difficulty coming up with meaningful and reasonable corrective (or preventive) action plans.
5
Proving effectiveness
Unable to demonstrate that actions actually tackled the root causes effectively.
6
Oversight & metrics
Losing visibility over overall quality metrics and progress across the organization.
What happens on a Gameplan call
I know what it feels like to be challenged — in audits, in investigations, and in the day-to-day firefighting of quality management. That experience is exactly what I bring to every client engagement.
In one focused conversation, we'll assess your current NC&CAPA performance, identify what's holding your team back, and begin drafting a tailored improvement strategy - at no cost to you.
Looking forward to speaking with you.
— Georg
In one focused conversation, we'll assess your current NC&CAPA performance, identify what's holding your team back, and begin drafting a tailored improvement strategy - at no cost to you.
Looking forward to speaking with you.
— Georg