## 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.

[**Manual assembly means manual errors**  
When reports are built from multiple data sources by hand, data gets transcribed incorrectly and inconsistencies slip through to submission.](/content/platform/pms-reporting#/index.html)

### 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.

[**By submission time, the data is already old**  
Formatting delays mean the complaint and adverse event data your report is based on is weeks out of date before it ever reaches a notified body.](/content/platform/pms-reporting#/index.html)

## 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

[Book a Personalized Demo](/content/demo/index.html)

**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.