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.
About Sterling Medical Devices
Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.
