MedTech Sustainability by Design

CAPA Done Right: How to Turn Quality Firefighting into Continuous Improvement with Georg Digel, Founder of Elevate CAPA

Lucas Pianegonda

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0:00 | 45:27

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

🔗 CONNECT WITH GEORG DIGEL: https://www.linkedin.com/in/georgdigel/?locale=de

🔗 CONNECT WITH US:
🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554
🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq
📺 YouTube – https://www.youtube.com/@GradicalGmbH
🌍 Gradical: https://gradical.ch/ 
📩 Work with us: lucas.pianegonda@gradical.ch


#MedTechSustainabilityByDesignPodcast #GradicalPodcast #MedTech #CAPA #QualityManagement #MedicalDevices #ContinuousImprovement #QMS #Compliance

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