Post-Market Clinical Follow-Up (PMCF)
Compliance Specialist
Global Regulatory Services
What We Offer
Post-Market Clinical Follow-Up (PMCF) Services
We design and manage PMCF activities to continuously evaluate the safety and clinical performance of medical devices after market placement. Our approach ensures MDR/IVDR compliance and supports proactive risk and lifecycle management.
PMCF Studies
Lifecycle Monitoring
- PMCF Planning & Study Execution PMCF plans, study protocols, data collection, and analysis aligned with MDR/IVDR
- Ongoing Safety & Performance Documentation PMCF reports, trend analysis, and regulatory-ready clinical follow-up documentation
We help medical device manufacturers comply with EU MDR (2017/745) requirements by implementing robust PMCF plans and reports to ensure ongoing safety and performance monitoring.
Deliverables to the Client
Deliverables
PMCF Plan
Includes timelines, responsibilities, and performance indicators.
Gap Analysis Report
Assesses existing clinical and post-market data against PMCF requirements.
Data Collection Tools & Protocols
Development of PMCF protocols, questionnaires, surveys, and data capture tools.
PMCF Evaluation Report
Analysis and interpretation of collected PMCF data for safety and clinical performance.
Integration with CER & PMS
Maintains consistency across lifecycle clinical evidence and risk management.
Regulatory Submission Support
Includes responses to queries and support during conformity assessments.
Benefits
Regulatory Compliance
Meet EU MDR Annex XIV PMCF requirements.
Enhanced Safety & Performance
Continuous monitoring ensures device reliability.
Risk Mitigation
Identify and address emerging risks proactively.
Market Confidence
Demonstrates commitment to patient safety and quality.
Streamlined Updates
Keep CER and PMS aligned with latest clinical evidence.
Benefits for Your Organization
Call To Action
Simplify Compliance. Accelerate Market Access.
Our global team supports medical device and IVD manufacturers with end-to-end regulatory, quality, and clinical services-ensuring safe, effective, and compliant products at every stage.
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