Tag: evaluation
FMEA for risk analysis and SQM ~ definition and evaluation
Die Fmeadie Method of error and analysis of the effect (in German “possible error and influenza analysis”) is a procedure to examine unknown effects known as known causes. For medical devices, FMEA is used, for example, in the analysis of the risk to analyze the consequences of a defective component, in particular the resulting danger.…
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Clinical validation vs. clinical evaluation
The term clinical validation it is also often used in relation to medical devices. For example, the BMBF publishes a guideline on the topic “Clinical validation of innovative medical technological solutions”. The FDA also talks about it clinical validation. What is clinical validation? How does it differ from a clinical evaluation and a clinical trial?…
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