Regulatory insights & practical guidance

Real-world strategies for Clinical Evaluation, PMCF, and MDR compliance. Read more about my experience from various projects and get actionable advice you can apply immediately.

Blog articles

PMCF
5 min read

Is your medical device still aligned with the State-of-the-Art?

Medical device manufacturers continuously have to evaluate the following question
PMCF
5 min read

Why do Notified Bodies keep seeing the same issues in Clinical Evaluations?

Why do the same issues keep appearing in Clinical Evaluations?
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