We Are The Pioneers of PMCF Survey Solutions For MDR Compliance since Jan 2018
Fast, Compliant, and Built for MDR Reality.
PMCF Surveys Conducted
Patient Case Forms
NB Approvals
Satisfied Clients
Our PMCF Survey Services
Our specialised MedTech team delivers validated evidence efficiently while ensuring every step withstands regulatory scrutiny.
PMCF Survey Plan
Comprehensive, regulation-aligned plans that set the foundation for a successful PMCF survey.
Sample Size Calculation & Survey Statistical Plan
Precise sample sizing and robust statistical frameworks to ensure data validity and MDR compliance.
Survey Design, Execution & Data Collection
End-to-end survey development, deployment, and high-quality data capture from real-world users
Data Analysis & PMCF Report Evaluation
Expert data interpretation and report assessment to deliver actionable safety and performance insights.
PMCF Survey Report
Regulator-ready PMCF reports with full analysis, safety/performance insights, and traceable CER-linked evidence.
Continuous PMCF Survey Monitoring
Ongoing tracking and periodic reviews to maintain compliance and detect emerging risks early.
Strengthen Your Clinical Evidence.
Accelerate Your Device Approvals.
MDR/MDCG Alignment
Fully compliant with MDR 2017/745, MDCG guidance, and NB expectations right from Day 1.
Evidence That Stands Up to Review
Rank-4–quality methodologies deliver stronger, unbiased insights that stand up to NB scrutiny.
Global Data Collection Capability
Surveys conducted across 60+ countries using verified HCP/patient panels GDPR/HIPAA compliant.
Faster NB Approvals
Clear timelines and structured justifications reduce reviewer queries and speed up acceptance.
MedTech Domain Expertise
Experience across Class I–III devices, diagnostics, implants, digital health, and more.
Audit-Ready Documentation
Every file includes full traceability, version control, data lineage mapping, and NB-style checklists—ensuring inspection-ready quality.
Case Studies
Speak with our PMCF team
Get a Rapid Assessment Of Your CER/PMCF Needs
Cetas Healthcare is a global leader in conducting ISO 14155-compliant Post-Market Clinical Follow-up (PMCF) surveys for MedTech devices. We specialize in designing and managing robust PMCF studies that capture real-world clinical evidence for Class II and III devices. To date, we’ve handled 25,000+ patient case forms, enabling clients to strengthen CE certification submissions and maintain full compliance with EU MDR requirements. By combining rigorous clinical research with actionable insights, we help MedTech companies continuously monitor device performance and enhance patient safety.
Contact Us: communication@cetas-healthcare.com
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