FDA Post-Market Surveillance

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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

August 26, 2021

FDA’s Software Precertification Program

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a...

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.

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!