Post-Market Surveillance Feedback Form

Post-Market Surveillance (PMS) refers to the activities conducted after a medical device, like a surgical instrument, is released to the market to ensure its continued safety, performance, and compliance with regulatory standards. It involves the collection and analysis of data from various sources, such as user feedback, adverse event reports, and clinical studies, to identify any potential risks, defects, or areas for improvement. The goal of PMS is to detect and address issues that may not have been identified during pre-market testing, ensuring the product remains safe and effective in real-world conditions. Regulatory bodies such as the FDA and EU’s MDR require manufacturers to implement robust PMS systems to maintain patient safety and product quality throughout the device’s lifecycle.

Effective PMS is critical in identifying emerging safety concerns, managing product recalls, and making necessary modifications to improve performance. Manufacturers are obligated to report adverse events, conduct regular performance reviews, and, in some cases, carry out post-market clinical studies. These activities help maintain compliance with international regulations and support the continuous improvement of medical devices. By actively engaging in PMS, manufacturers not only safeguard patient health but also enhance their product’s long-term effectiveness and reliability, fostering trust with healthcare providers, regulatory authorities, and end-users.

You can submit your report at our dedicated PMS email, pms.monitoring@prowainstruments.com, or you can submit the form below.