DHF Remediation
If you need a legacy product Design History File (DHF) to meet current standards, or if your product line is not in conformance with your quality system, Sterling Medical Device’s DHF Remediation Service can help. Sterling Medical Devices offers DHF Remediation services which involve
- Creating and updating the design information necessary to validate and maintain the device throughout its lifecycle.
- Assistance in pinpointing design decisions that create problems for device users
- Gap analysis of your design history file to identify disparities between your medical device DHF and FDA requirements
Our experts can help you perform any necessary activities to fulfill your design history file needs while working under your Quality System. We make sure all design history files for your existing products are complete, accurate, robust, and up to standard. Contact us to learn more about our DHF Remediation services.