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DHF Medical Device Remediation

Design History Files (DHF) are a compilation of records that describe the design history of a finished device, including design review, verification, and validation. The U.S. Food and Drug Administration (FDA), as well as other regulatory bodies around the world, require DHFs as part of design controls. As regulatory requirements change and you update your quality system, it is important to ensure that DHF for legacy products are compliant with the new standards.

Sterling Medical Devices can help.

We offer DHF remediation services to create and update the design information necessary to validate and maintain your device throughout its lifecycle. Whether you need to update a legacy product DHF to meet current standards or your product line does not conform to your quality system, Sterling Medical Device’s DHF remediation service offers you the support you need.

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

We have the right team to make your DHF remediation effortless. Our experts can help you perform any DHF remediation activities while working under your quality system. We’ll do what it takes to make sure all DHF for your existing products are complete, accurate, robust, up to standard, and ready for the next audit.

Resources

Doctor examining medical device report

December 20, 2021

A Guide to FDA Design Controls for your Medical Device

Medical devices hold great responsibility and risk – if they aren’t working properly, there could be dire consequences for a person’s health and potentially life. Because of this, they are...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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