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Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
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FDA Post-Market Surveillance

Stay compliant in any market. Unload the burden of post-market surveillance activities to the experts!

We offer full-service Post-Market Surveillance (PMS) planning and execution for all markets, for every device classification and all clinical specialties. Regulations related to PMS vary throughout countries and regions. With laws changing regularly, staying compliant can be tricky. It’s important to have a deep understanding of the marketing and reporting requirements in each jurisdiction for your device classification. Our team of professionals has extensive experience in PMS compliance in the US, EU, Canada, and more. We will work with you to develop a risk-based approach to PMS processes to ensure that your product complies with the necessary regulations in every market.

With our in-depth product knowledge covering a wide range of functional and technical disciplines, we provide comprehensive services related to post-market risk management activities. We can help:

  • Integrate risk management into your PMS processes,
  • Establish PMS processes,
  • Post-market clinical follow-up (PMCF) plans and reports,
  • PMCF surveys and reports,
  • Periodic Safety Update Reports (PSURs),
  • Investigate adverse events, and more. 
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We understand that managing post-market surveillance processes can be complex, so let us help you stay compliant in any market! Contact us today.

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.

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Resources

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August 9, 2022

Using Regulatory Strategy to Reduce Medical Device Time to Market

Using Regulatory Strategy to Reduce Medical Device Time to Market According to recent estimates (1), the global medical device market is expected to grow from over $455 billion in 2021 to...
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5 Mistakes Medical Device Startups Make

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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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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