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.
Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable...
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.
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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