Post-Market Surveillance (PMS) is the most critical feedback loop in a medical device's lifecycle. Yet, many companies still treat it as a reactive, annual reporting exercise.
The Shift from Reactive to Proactive
Under MDR, PMS must be proactive. This means you shouldn't wait for a complaint to come in. You need to actively gather data from clinics, literature, and even social media if relevant.
Three Pillars of a Masterful PMS System
- Real-time Data ingestion: Use automated tools to scan medical databases (PubMed, EMBASE) for mentions of similar devices or technologies.
- Standardized Trend Reporting: Define clear "noise floors" for incidents. When a trend exceeds standard deviation, it should automatically trigger a CAPA investigation.
- Clinical Evaluation Update: The PMS data must feed directly back into the Clinical Evaluation Report (CER). A CER that hasn't been updated with PMS data is a major audit risk.
A robust PMS system doesn't just satisfy auditors—it identifies design flaws early and protects your brand reputation.
Author
We are thrilled to have Shramik Kamat share their opinion on our blog. As a valued member of the Medbash team, Shramik Kamat brings a wealth of expertise and insights to our readers. Their contributions help us stay at the forefront of medical device compliance and innovation.
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