Automated Post-Market Surveillance Reporting : From 100+ Hours to Just 8 Minutes
Smarteeva has fully automated the generation of post-market surveillance reports. EU PSUR, UK PSUR, EU PMSR, UK PMSR, PMPF-ER, and HCSR - produced in minutes, not weeks, by pulling data directly from your complaint and quality records.
- Pulls data from all your records
- Maps fields to regulatory requirements
- Produces audit-ready documents in minutes
Manual PMS reporting make you team spend 100+ hours per report, per product family, per reporting period.
Your analyst can only review so much
When bandwidth is limited, trends get missed. A subset of the data gets reviewed, and the rest goes unexamined until an auditor asks about it.
Smarteeva generates complete, audit-ready PMS reports in 8 minutes.
What gets automated
Smarteeva automates the generation of the following post-market surveillance reports:
EU PSUR (Periodic Safety Update Report)
Required under EU MDR Article 86 for Class IIa, IIb, and III devices. Smarteeva compiles complaint data, adverse event summaries, trend analyses, risk-benefit assessments, and conclusions into a complete PSUR document.
PMPF-ER (Post-Market Performance Follow-up Evaluation Report)
For IVD manufacturers under IVDR. Smarteeva compiles performance data, complaint trends, and clinical evidence into the required evaluation report format.
EU PMSR (Post-Market Surveillance Report)
Required under EU MDR Article 85 for Class I devices. Smarteeva generates the PMSR with updated complaint data, PMS activities, and conclusions on the need for corrective or preventive action.
UK PMSR
The UK MDR equivalent, generated with UK-specific regulatory alignment.
HCSR (Health Canada Summary Report)
Aligned with Health Canada's post-market surveillance reporting requirements.
What the AI Does
Data Collection
Pulls all relevant complaint records, adverse event reports, field safety corrective actions, investigation outcomes, and CAPA data for the specified product family and reporting period. No manual data gathering required.
Statistical Analysis
The FDA expects systems that reliably identify and report adverse events within required timelines. EU MDR requires active post-market surveillance with vigilance reporting. Every major regulatory framework in the world demands that you catch reportable events and file them on time.
Trend detection
Organizes data into the regulatory-required sections of the report: product description, PMS plan summary, complaint and adverse event analysis, trend evaluation, risk-benefit assessment, and conclusions.
Document Generation
Produces a complete, formatted document ready for your regulatory team's expert review, revision if needed, and submission.
What Your Team Does
Your team reviews the output, applies clinical judgment, and submits. That's it.
Review the generated report
Your team opens a complete, pre-assembled document. Data gathered, tabulated, and formatted. Already done.
Add expert judgement
Interpretation, risk-benefit analysis and regulatory strategy. The parts that actually require human expertise.
Submit with confidence
Conclusions verified, document formatted to agency specifications. No last-minute scramble. No stale data.
The math matters
For a medical device company with 10 product families, each requiring annual PMS reports:
Manual Process
100+ hours per report × 10 products = 1,000+ hours/year
3-4 regulatory professionals dedicated to report assembly
Reports based on data that's weeks old by completion
Manual formatting, inconsistent structure
With Smarteeva
8 minutes per report × 10 products = 80 minutes/year
Regulatory team redirected to submission quality and strategic work
Reports generated from real-time data
Standardized, regulatory-formatted output every time
Questions? We’re glad you asked.
How does Smarteeva generate a PMS report in 8 minutes?
Smarteeva's AI automatically pulls complaint data, adverse event records, and quality data for the specified product and period, computes statistical summaries, detects trends, assembles regulatory-required sections, and produces a complete formatted document — all without manual data gathering.
Which PMS report types does Smarteeva support?
EU PSUR, UK PSUR, EU PMSR, UK PMSR, PMPF-ER (IVDR), and HCSR (Health Canada).
Do we still need to review the reports?
Yes. Smarteeva generates the report and does the data assembly. Your regulatory team reviews the output, adds expert commentary, ensures conclusions are accurate, and submits. The AI handles the labor; your team provides the judgment.