PSUR Reports
Generate Periodic Safety Update Reports as required by EU MDR for Class IIa, IIb, and III devices. Compile comprehensive safety data, trend analyses, and benefit-risk conclusions in a structured format ready for submission to regulatory authorities.
Key Capabilities
What you get with the PSUR Reports module.
How It Connects
PSUR Reportsdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.
Ready to see PSUR Reports in action?
Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how PSUR Reports works within your specific compliance context.
More in Clinical & Post-Market
Explore other modules in the Clinical & Post-Market category.
Clinical Investigations
Plan and manage clinical investigations for medical devices with structured study management covering protocol development, site management, and regulatory submissions. Ensure your clinical studies meet ISO 14155 and EU MDR requirements from start to finish.
Clinical Evaluations
Conduct and document clinical evaluations as required by EU MDR and MEDDEV 2.7/1 Rev 4. Systematically assess clinical data from literature, clinical investigations, and post-market surveillance to demonstrate safety and performance of your devices.
Literature Reviews
Conduct systematic literature reviews to support clinical evaluations, risk management, and post-market surveillance activities. Document your search strategies, screening criteria, and analysis results in a structured format that meets regulatory expectations.
PMCF Plans
Develop Post-Market Clinical Follow-up plans that define your strategy for proactively collecting clinical data after market placement. Meet EU MDR Annex XIV Part B requirements with structured PMCF plans that identify methods, milestones, and evaluation criteria.
PMCF Evaluation Reports
Document the results of Post-Market Clinical Follow-up activities with structured evaluation reports. Analyze PMCF data to confirm ongoing safety and performance and identify any emerging clinical risks that require action.
PMCF Reports
Generate comprehensive PMCF reports that summarize all post-market clinical follow-up activities and findings. Create regulatory-ready documents that demonstrate ongoing clinical data collection and analysis as required by EU MDR.