Technical Documentation FileTechnical Documentation FileTechnical Documentation FileTechnical Documentation File
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Swiss Importer Identified with MDD/AIMDD
May 16, 2023
Unique Device Identifier
December 8, 2023

Technical Documentation File

December 8, 2023

Draft a Technical Documentation File (TDF).

 

A TDF is made up of the following elements:

 

  1. Main Body that describes the device and verifies how the device has met the all the applicable general safety and performance requirements
  2. Performance Evaluation (procedure, plan and report)
  3. Risk assessment conducted for the device
  4. Post-market surveillance system
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