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Notified Bodies raise concern on Risk Grading

Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does

Risk Management mistakes that could cost you your certification!

In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities: flawed risk grading strategies.

If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call.

What you’ll learn:

The most frequent audit findings related to risk grading

Real-world case studies…

The skinny

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