Medical Device File (Technical File) Creation

A Medical device technical file is a compilation of the documentation required to demonstrate compliance to the relevant regulation. The file contains details of the design and intended use, as well as evidence of the safety and effectiveness of the device. The technical file must be kept up-to-date throughout the life-cycle of the device and must be made available on request of the competent authority. Patient guard specialises in the regulatory requirements for the EU and UK markets and have assisted clients in producing technical files to the necessary regulation.

UKCA Marking Technical Files

Are you developing a medical device or in vitro diagnostic device with the intent to sell to the UK market?…

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CE Marking Technical Files

Are you developing a medical device or in vitro diagnostic device with the intent to sell to the European market?…

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