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 of 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 Sterling Medical Devices comes in.

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

Sterling Medical Devices can help with quality systems

Tell Us How We Can Help

If you need to update a legacy product design history file to meet current standards or if your product line does not conform to your quality system, Sterling Medical Device’s DHF Remediation Service can help. We offer the extensive resources and understanding obtained through our 18 years in business to make your DHF remediation effortless.

We start by fully understanding your situation and medical device. Then, we perform a gap analysis of your design history file to identify disparities between your medical device DHF and what the FDA currently requires. Based on those findings, Sterling Medical Devices works with you to develop and then implement a DHF remediation plan.

Why Sterling

The Right Team for Your Design History File Needs

Working under your Quality System, we retrospectively perform any necessary activities to bring your DHF up to date in a timely, cost-effective manner. This enables your R&D team to stay focused on new development.

We’ll do what it takes to make sure all design history files for your existing products are complete, accurate, robust, up to standard, and ready for the next audit. Find out more about why our DHF Remediation Service is the right fit for you. Call Us Today.