A lot of MedTech companies treat CAPA as a compliance exercise. They open a record, close a record, and survive the audit. Georg Digel has spent his career watching what happens when that's the only goal… and it's not pretty.
Georg is the Founder and Owner of Elevate CAPA. He has spent years helping MedTech companies build CAPA systems that actually work: ones that identify real problems, trace them to their root cause, and prevent them from coming back.
Here's what we get into:
Why CAPA is one of the most misunderstood processes in medical technology
The difference between a non-conformity and a CAPA
What auditors actually find when they inspect CAPA systems
Why "death by CAPA" happens and how to avoid it
How management culture makes or breaks the whole thing
What a lean, functional CAPA process looks like in practice
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