Design history files are a compilation of records which describes the design history of a finished device, including design review, verification, and validation. This is required by the FDA as part of Design Controls (21 CFR 820.30), a subsystem within the main Quality System. A well-established, formal, Design Control process will ensure that the DHF contains all the records required by the FDA.

As the FDA updates medical device regulatory requirements and you update your Quality System, you must ensure that the design history files for your legacy products stay compliant. That is where we can help.

We offer DHF Remediation services to create and update the design information necessary to validate and maintain the device throughout its lifecycle. This includes the identification of “gaps” in the existing technical documentation followed by the creation or update of the documentation to comply with applicable standards, regulations, and FDA guidance.

Benefits of medical device design history file remediation include:

  • Assistance in pinpointing the design decisions that create problems for device users
  • Retention of intellectual property through proper documentation
  • Improvement of similar future projects by keeping track of developmental dead ends
  • Proof that the device is in accordance with the approved design plan and the requirements of the FDA’s Design Controls, resulting in streamlined audits