On-Demand Webinar
New medical devices and products are often placed on the market with a limited understanding of their risks and benefits; therefore, manufacturers, regulators, payors, users, and patients rely on a robust post-market surveillance (PMS) system.
While PMS has traditionally been a passive activity—often limited to managing complaints and submitting incident reports—reporting alone cannot capture all the risks related to the safe and effective use of medical devices.
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About This Webinar
In this webinar, we discussed how PMS can go from a passive to a proactive process that continuously feeds real-world evidence back into the quality system. Topics covered include:
- Changes in global PMS requirements
- Qualities of a modern PMS system
- How to obtain better clinical and safety data
- Standards that underlie global QMS requirements
- Q&A
What You'll Learn
- How global post-market surveillance requirements are changing and what they mean for device manufacturers.
- The qualities that distinguish a modern, proactive PMS system from a passive, complaint-only approach.
- Practical ways to obtain better clinical and safety data across the product lifecycle.
- The standards that underlie global quality management system (QMS) requirements and how they connect to PMS.
- How to turn reporting into a continuous source of risk and benefit insight rather than a reactive obligation.
The USDM point of view: Post-market surveillance is most valuable when it is treated as a connected, data-driven discipline—not a downstream paperwork exercise. When PMS data flows reliably into the quality system and the right controls govern that data, manufacturers can detect risk earlier, support safe and effective use, and stay ahead of evolving global requirements. That depends on trustworthy systems, validated software, and sound data integrity practices underpinning every record.
Why Proactive PMS Matters
The systems that collect, store, and act on surveillance data sit inside a regulated environment. Whether you are modernizing complaint handling, integrating new data sources, or qualifying the tools that support PMS, the underlying software and records must hold up to scrutiny. A risk-based validation approach such as Computer Software Assurance (CSA) helps teams focus effort where patient safety and product quality are most at stake, while 21 CFR Part 11 compliance keeps electronic records and signatures defensible.
Frequently Asked Questions
What is medical device post-market surveillance (PMS)?
Post-market surveillance is the ongoing process of monitoring the safety and performance of a medical device after it has been placed on the market. Because new devices often enter the market with a limited understanding of their full risks and benefits, manufacturers, regulators, payors, users, and patients rely on a robust PMS system to capture real-world information about safe and effective use.
Why is traditional, passive PMS no longer enough?
Traditional PMS has often been a passive activity limited to managing complaints and submitting incident reports. Reporting alone cannot capture all the risks related to the safe and effective use of a device, which is why the webinar focuses on shifting PMS from a passive to a proactive process that actively gathers better clinical and safety data.
What does a modern PMS system look like?
A modern PMS system is proactive rather than reactive. As discussed in the webinar, it reflects changes in global PMS requirements, embodies the qualities of a modern surveillance approach, supports gathering better clinical and safety data, and aligns with the standards that underlie global QMS requirements.
How do quality and compliance requirements relate to PMS?
PMS does not operate in isolation—it is tied to the standards that underlie global quality management system (QMS) requirements. The data and systems supporting surveillance must be reliable and well governed, which connects PMS to broader practices around validated software, electronic records, and data integrity.
Who should watch this webinar?
This on-demand session is geared toward medical device manufacturers and quality, regulatory, and safety professionals who want to understand changing global PMS requirements and build a more proactive surveillance system. The webinar is presented by Jay Crowley, Vice President of Medical Device Solutions and Services.
Watch the on-demand webinar: Fill in the form and click Watch Now to access the full session on reimagining medical device post-market surveillance. To talk through how USDM can help modernize your PMS and quality systems, contact our team.
About the Presenter
Jay Crowley, Vice President of Medical Device Solutions and Services