A procedure that describes how to prepare the Technical File and how to complete the individual sections. It also indicates what needs to be taken into account when verifying that individual reports have been prepared in accordance with the requirements of the MDR and other relevant regulations.
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There are 4 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: Technical File Template and Technical Documentation Checklist, Summary of Safety and Clinical Performance and List of UDI-DI.
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