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GSPR Checklist Template - MDR 2017/745

GSPR Checklist Template - MDR 2017/745

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ISO 13485 - QMS. - GSPR Checklist Template MDR 2017/745

The General Safety and Performance Requirements (GSPR) checklist is a checklist against annex I of the Medical Device Regulations (MDR) EU 2017/745. The device needs to be assessed against each clause of annex I, and evidence presented on how the requirements has been met and where the evidence is located, or a justification as to why the requirement is not applicable, just writing not applicable is not sufficient. This template provides a full list of annex I clauses and formatted to easily present the data required to demonstrator conformity to the MDR.

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