Automated Post-Market Surveillance (PMS) Reporting - From 100+ hours to just 8 minutes
Our platform has fully automated the generation of reports such as EU PSUR, UK PSUR, EU PMSR, UK PMSR, PMPF-ER, and HCSR.
Smarteeva integrates PSUR, PMSR, HSCR and UK reports on a single platform.
With Smarteeva’s Unified PMSR, MedTech organizations gain complete visibility and control over post-market reporting. By connecting Snowflake, ERP, and RIMS through API integrations, Smarteeva eliminates manual effort and enables automated, template-driven report generation. Teams can now work on multiple reports. simultaneously, track changes with timestamps, and validate completeness through built-in error alerts.
Automated Report Creation
Our system tackles the complexity of multi-region reporting head-on. You'll be able to generate EU MDR-compliant PSURs, PMSR, PMCFs as well as HSCR and UK Reports with 1 click.
Multi-Region Compliance
Whether you're navigating EU MDR, FDA requirements, UK MHRA rules, or WHO guidelines, the module accommodates different regulatory frameworks. For Class III and implantable devices in Europe, there's a workflow built in for PSUR submission to your Notified Body via EUDAMED. Legacy devices transitioning under MDR? The system manages compliance tracking for those, too.
Risk Monitoring & Assessment
Tracking risk patterns happens continuously, not just when you're pulling together a report. The system flags emerging safety signals early, before they escalate into serious problems. You document benefit-risk assessments right in the platform, and those evaluations maintain connections to your risk management files. When you're dealing with serious incidents, IMDRF coding standards are supported.
Data Consolidation
Manual PMS usually means hunting through different systems. We've consolidated that. Adverse events, complaints, customer feedback, clinical follow-up findings, market intelligence - it all lands in one place. Sales volumes and exposure estimates sit alongside safety data so you can actually calculate meaningful incidence rates.
CAPA Connection
Sometimes, post-market data points to an issue that needs corrective action. When that happens, you can create CAPA records directly from the PMS module. The connections between findings, actions, and verification steps stay intact, which makes life easier during audits when you need to demonstrate how you addressed safety concerns.
Documentation Control
The audit trail captures every change, giving you a complete modification history. Reports function as living documents - they evolve as new data accumulates. Version control handles this naturally. Access permissions keep report editing and approval limited to authorized personnel.
Meeting Regulatory Obligations
PMS isn't something you can skip - it's mandatory, and the consequences for non-compliance are real. A systematic approach ensures timely report filing, keeps documentation audit-ready, and helps you sidestep the compliance problems that lead to warning letters or market restrictions. When inspectors or notified bodies ask for PMS documentation, having everything organized and accessible matters significantly.
Streamlined Operations
Traditional manual PMS reporting goes something like this: gather data from emails, multiple spreadsheets, complaint logs, and various databases. Consolidate everything into Word docs or PDFs. Based on what we've heard from customers, this can eat up weeks of staff time. Automated data collection and report generation compress that timeline dramatically. Your team spends less time on administrative work and more on actual analysis and decision-making.
Better Safety Outcomes
The real payoff from post-market surveillance is catching problems before they become widespread. Continuous data tracking reveals safety signals much earlier than waiting until the report deadline season to look at everything. Earlier detection means faster corrective actions, which means fewer patients potentially affected. Throughout the device lifecycle, ongoing monitoring tells you whether the benefit-risk profile established during pre-market testing actually holds up when the device hits real-world use.
Product Development Insights
Post-market data surprises you sometimes. Devices perform unexpectedly well in certain patient populations. Clinicians develop novel usage techniques you didn't anticipate. Field experience reveals improvement opportunities. All of this real-world evidence should loop back into product development and inform next-generation design decisions. The same data can strengthen marketing claims and support conversations with payers.
Resource Management
Setting up proper PMS requires initial investment, yes. But it generally reduces costs long-term. Proactive monitoring helps you avoid expensive recalls and market withdrawals. When field actions do become necessary, solid data helps you scope them appropriately instead of implementing overly broad precautionary measures. The efficiency gains from automation mean smaller teams can handle larger device portfolios.
Market Positioning
Meeting regulatory requirements is a baseline. Strong post-market surveillance demonstrates a commitment to quality that goes beyond compliance checkbox-checking. Healthcare providers increasingly expect manufacturers to stand behind their products after the sale. Robust PMS capabilities can differentiate your company when you're competing for hospital contracts or responding to tender requirements.
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Advanced features including machine learning and smart audit trail
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