ISO 13485 & EU MDR / Clinical Evaluation
Which area of ISO 13485 covers or fits the Clinical Evaluation part? Is it only in "7.3.7 Design and development validation"?
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Yes, you're right, Clinical evaluation is covered in requirement 7.3.7 Desing and development validation.
In our ISO 13485:2016 & MDR Documentation toolkit we have prepared the necessary documentation for clinical evaluation according to the MDR. You can see its preview on the following link:
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