Your firm does not have a design history file (DHF) for the Meridian DR 200 single panel X-ray system. The system is comprised of a workstation, flat panel detectors, acquisition software and X-ray hardware. Missing elements of the DHF include:
• A design plan for the project
• Established or approved design inputs/outputs for the system
• Verification or Validation testing for the system
• Design Transfer
• Risk Management for the system
• Design Reviews.
Your firm does not have procedures to describe the content of your Device History Records (DHR’s). In addition, eleven of eleven DHR files reviewed showed that all were incomplete as the only record in the files was your testing of the flat panel detectors, which is only one part of the X-ray system. The DHRs do not include installation records; records of any non-conformities; records regarding the X-ray hardware, workstation or acquisition software; or records of final product testing and quality release of your systems.
View the original warning letter.