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GSPR Checklist Template - IVDR 2017/746

GSPR Checklist Template - IVDR 2017/746

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General Safety & Performance Requirements (GSPR) Checklist Template IVDR 2017/746

The General Safety and Performance Requirements (GSPR) checklist is a checklist against Annex I of the In Vitro Diagnostic Device Regulations (IVDR) EU 2017/746. 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 IVDR.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

IVD Regulatory Support:

If you are looking for support with your IVD compliance then Patient Guards consultancy services could be a cost effective solution for your organisation.

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