Vigilance Never Sleeps.
Setting up a Proactive PMS system is mandatory under MDR. We analyze complaints, literature, and databases to generate your PMS Reports and PSURs.
Automated Literature Search
We continuously scan for adverse events related to your device or similar devices in literature and MAUDE/EUDAMED.
Trend Analysis
We statistically analyze your complaint data to detect rising trends before they become reportable incidents.
PSUR Generation
For Class IIa and above, we author the Periodic Safety Update Report (PSUR) ready for Notified Body submission.
Proactive, Not Reactive.
Closed Loop
We ensure PMS findings feed back into Risk Management and Clinical Evaluation (CER).
Regulatory Intelligence
We use our RegIntel AI to spot field safety notices from competitors that might affect your risk profile.
Resource Relief
Free up your QA team from the tedious task of reading hundreds of abstracts and complaints.
The PMS Cycle
Data Collection
Gathering complaints, service reports, user feedback, and literature.
Analysis & Trending
Reviewing data for signals. Updating Risk Management Files if severity/frequency changes.
Reporting
Compiling the PSUR or PMSR. Updating the SSCP (Summary of Safety and Clinical Performance).
PMS Outputs
Frequently Asked Questions
Is PMS mandatory for Class I?
Yes, even Class I needs a PMSR (Report) updated when needed.
What's the difference: PMSR vs PSUR?
PMSR is for Class I via MDR. PSUR is for Class IIa and higher, requiring stricter updates.
Do you handle vigilance reporting?
Yes, we can prepare MIR (Manufacturer Incident Report) forms for authorities.