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:

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.

Resources

Letters GLP, representing Good Laboratory Practice

February 14, 2022

Preparing for GLP Guideline Regulations in Medical Device Development

Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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....
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