EUMDR Support
End-to-end EU-MDR support for a Class III legacy medical device using PMCF survey
500+ survey data collected across the USCAN and Europe in 8 weeks!...
Case Studies: Proven PMCF Impact. Real Results.
CIP
Clinical Investigation Plan for Wound Dressing
A randomized controlled clinical investigation designed to assess safety...
PMCF Survey
PMCF Survey for PICC Catheter
A 3-phase PMCF survey approach designed to collect 575 high-quality clinical...
PMCF Survey
PMCF Survey for Venous Access Port
A structured 3-phase PMCF program designed to collect 200 high-quality case...
CER
Achieving EU-MDR Compliance for a Class IIb Glaucoma Implant
The client a global medical techno glaucoma implant for EU-MDR compliant...
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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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