In this blog, we have provided tips to perform effective post-market surveillance under EU-MDR. What is post-market surveillance under EU-MDR? Post-market surveillance under EU-MDR is the structured process by which manufacturers continuously monitor the safety,...
Medical device single audit program (MDSAP) is a comprehensive audit framework designed to meet regulatory requirements of multiple participating countries. MDSAP post‑market surveillance requires manufacturers to maintain a harmonized, risk‑based system for...
Post-market surveillance (PMS) for software as a medical device (SaMD) is a critical regulatory and operational requirement. It ensures ongoing safety, performance, and compliance once the product is launched in the market. SaMDs are reshaping modern healthcare. They...
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