FDA Post-Market Surveillance

Post-market

Before bringing your device to market, you went through a series of rigorous regulatory processes to get it approved for commercialization. But because some risks manifest over time, the U.S. Food and Drug Administration (FDA) requires post-market surveillance (PMS) of your device to ensure its continued safety and effectiveness in the real-world setting.

Post-market evaluation of your device can be time-consuming, cumbersome, and complex, presenting a challenge for many manufacturers. At Sterling Medical Devices, this is what we do—and we do it exceptionally well.

Sterling can help.

Our team of experts can help you create PMS and post-market follow-up (PMCF) plans and reports; integrate risk, clinical evaluation reports (CER), and PMS processes; and develop and execute on PMCF surveys and usability data.

We’ll also help you identify areas of negative impact to mitigate the risk of potential issues, then provide easily attainable avenues for remediation when necessary. Our remediation expertise includes:

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At Sterling, we understand the legal requirements of the federal Food, Drug, and Cosmetic Act (FD&C) and related statutes enforced by the FDA. We also know the legal and regulatory requirements for medical product development, marketing approval, reporting requirements, inspections, and enforcement actions. When it comes to the increasingly complex world of post-market surveillance, follow up, and remediation, we’ve got you covered. 

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

July 29, 2015

White Paper – 4 Factors to Consider When Developing Your mHealth Product

4 Factors to Consider When Developing Your mHealth Product Successful FDA submission of your mHealth product not only hinges on the accuracy of your data and reliability of your software, but on...
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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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