As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a strategic advantage.
According to global regulatory experts, the ability to predict, monitor, and act on post-market data is fast becoming a benchmark for excellence in medical device oversight. While the U.S. FDA and the European Union (EU) both prioritize PMS, their frameworks reflect two distinct philosophies: the FDA’s reactive yet data-driven model versus the EU’s proactive, lifecycle-integrated system under MDR 2017/745.
For companies with global aspirations, understanding these nuances in 2025 is essential to safeguarding brand reputation, achieve compliance, and maintain market access.
Understanding Post-Market Surveillance (PMS)
Post-Market Surveillance refers to the ongoing and systematic collection, analysis, and interpretation of data related to a medical device after it is placed on the market.
Comments
Log in or sign up to join the conversation.