Implementing a Medical Device Post-Market Surveillance Program
Questions? Request more information from our specialists
CONTACT USHow do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality. PMS is a regulatory requirement in major markets like Europe and United States.
When done right, your PMS system can improve your device, provide better service to your users, and reduce the risk of adverse events before they happen. But with a myriad of regulatory obligations looming over you, implementing a PMS system can be overwhelming. What you will learn in this 6-page white paper:
- What is the difference between PMS and vigilance?
- What are the key elements of a PMS system?
- How should a PMS system function?
- What is the role of risk management in PMS?
- How do I implement data collection and review procedures?
- How does a PMS system benefit my company?
We answer all of these questions and many more in this white paper.
About the Author
Elizabeth Pugh: Elizabeth Pugh is a Regulatory Affairs Consultant at Emergo. She has over 15 years of experience with regulatory affairs in the medical devices industry, and previously held positions at Stryker, FoxHollow Technologies, and DJO Surgical. Her areas of expertise include CE Marking compliance, post-market surveillance, and global vigilance reporting.
Related
-
WATCH NOW: Risk Management according to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read more -
Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)
Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming
read more