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Clinical Evaluation

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Guest user Created:   Jan 29, 2021 Last commented:   Feb 01, 2021

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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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 01, 2021

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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Jan 29, 2021

Feb 01, 2021