Technical Documentation covers the terms Technical File and Design Dossier.

Assembling the Technical documentation to support a medical device regulatory submission is a combines a number of skills:
•    an understanding of the clinical utility of the device
•    the technologies employed in the medical device
•    guidance on what validation and verification processes are required
•    knowledge and understanding of what the law demands
•    the file structure to enable a satisfactory review of the file by a Regulatory Agency
•    last, but not least, writing skills!
Priory Analysts will construct the Technical Documentation with the appropriate level of detail for the classification of device being developed. We ensure it captures into a single, identifiable location all the records of product design, development and testing and also satisfies the scrutiny of Regulatory Agencies.
This service is called Tech-paCE