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.

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Part of Clinical & Post-Market

Clinical Investigations Literature Reviews PMCF Plans PMCF Evaluation Reports PMCF Reports PMS Evaluations Post-Market Surveillance PSUR Reports PSUR Evaluations

Regulatory Context

EU MDR Article 61 — Clinical evaluation

MEDDEV 2.7/1 Rev 4 — Clinical evaluation: a guide for manufacturers and notified bodies

EU MDR Annex XIV — Clinical evaluation and post-market clinical follow-up

Key Capabilities

What you get with the Clinical Evaluations module.

Structured clinical evaluation plans with defined scope and methodology

Clinical data identification, appraisal, and analysis workflows

Literature review integration with relevance and quality assessment

Clinical Evaluation Report generation meeting EU MDR Annex XIV requirements

Periodic CER updates triggered by new clinical data or post-market findings

Why It Matters

How Clinical Evaluations helps your organisation.

Make evidence-based decisions with a structured clinical data appraisal process

Accelerate notified body reviews with well-organised Clinical Evaluation Reports

Keep clinical evidence current through periodic updates triggered by new data

How It Connects

Clinical Evaluationsdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Literature Reviews PMCF Plans Post-Market Surveillance

Ready to see Clinical Evaluations in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Clinical Evaluations works within your specific compliance context.

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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.

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.

PMS Evaluations

Conduct periodic post-market surveillance evaluations that aggregate and analyze data from complaints, vigilance reports, literature, and other sources. Identify trends and emerging issues to support proactive quality and safety management for your marketed devices.