The Importance of Post-Market Clinical Follow-up (PMCF)

The Importance of Post-Market Clinical Follow-up (PMCF)

Under the EU MDR, post-market surveillance (PMS) is a critical quality control measure designed to identify risks associated with a device after being used for some time. Post-market clinical follow-up (PMCF) is an important part of a manufacturer’s PMS and is used to:

  • Verify the clinical performance of a product and confirm the safety
  • Ensure the continued acceptability of the previously identified risks
  • Detect new risks based on factual evidence

This whitepaper provides valuable insights and tips to help conduct an effective PMCF study to ensure that better, lower-risk products are being brought to market, reducing unavoidable residual risks to acceptable levels. 

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Resources

September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...
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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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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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