Struggling with your Design History File? Looking for a partner that completes the file for you?

It is good to know that our experts can help you.

The Design History File (DHF) is a compilation of all documents and experimental records that describes the design history of a finished medical device. Our delivery manager builds and maintains the file during the project process. Finally, the customer owns the complete DHF.

We complete the DHF for you, including the following content:

  • Contract (copy)
  • Confidentiality agreement (copy)
  • Project Plans
  • Specification Settings Forms
  • Manufacturing Requirements Document
  • Feasibility and Optimization, Verification, Validation, Technical Transfer, Production, Stability Plans and reports
  • Quality Control and Specifications Protocol
  • Final Manufacturing and QC documents
  • Device Master Record
  • Minutes of Technical Settings
  • Formal Review Meeting Summary Reports
  • Risk Management Reports
  • RACI-Matrix
  • Finalized Trace Matrix
  • Calibration Transfer Protocol
  • Data Research and Optimization Studies
  • Verification Results
  • Validation Results
  • Stability Results
  • Acknowledgement of DHF receipt