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The 4 Most Common Mistakes in the Risk Acceptance Matrix

In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was...

Risk acceptance threshold: How many deaths are we willing to accept?

There are increasing reports from the field that insufficiently justified risk acceptance limits have led to problems with product...

The underestimated value of "clinical benefit" in medical device risk management

In the MDR, the benefit-risk ratio is given a much higher priority than was the case in the MDD. The frequency with which the term...

How to minimize risks "as far as possible" in MedTech

The MDR demands in Annex I that medical device manufacturers must minimize risks "as far as possible". In this context, medical device...

FMEA is not risk analysis!

Over the past few decades, medical device manufacturers have used FMEA (Failure Mode and Effects Analysis) as a risk analysis tool....