DHF Remediation

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.

 
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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.

Resources

Notes reading FDA recall signify the consequences of medical device failure

January 26, 2022

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm By manufacturing and providing a medical device, you are taking on a big responsibility....
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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