In the dynamic world of medical devices ensuring safety, performance, and efficacy doesn’t end after receiving regulatory approval and market entry. Post-market surveillance (PMS) and Vigilance are pivotal in maintaining ongoing device safety and staying in compliance. These processes enable regulatory affairs professionals to detect, evaluate, and act upon any issues that might arise after a medical device is made available to the public.
In this post, Adi Ickowicz analyses all the key steps to stay compliant after the approval and market entry of a medical device, such as: Post-Marketing Surveillance, Adverse Event Reporting, Vigilance and the Benefits of Effective PMS.
Read the whole article here: Navigating the Crucial Landscape of Post-Market Surveillance (PMS) and Vigilance in Medical Device Safety, Performance, and Efficacy
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