Scalable & Transparent Clinical Documentation Services for Compliance
Our Clinical Strategy and Support Services
CEP Services
- Reviewing current Clinical Evaluation Plans
- Updating plans according to new regulations
- Providing remediation strategies if gaps are found
CER Services
- Drafting and Reviewing CERs
- Updating CERs with new data
- Addressing any gaps or compliance issues
- State-of-the-Art (SOTA) assessments
- Clinical claims mapping & benefit–risk analysis
Clinical Literature Review (SLR — PRISMA compliant)
- Performing systematic literature searches
- Summarizing relevant findings
- Ensuring evidence supports product claims
Post-Market Surveillance (PMS)
- Drafting and Reviewing PMS Plans
- Drafting and Reviewing PMS Reports & PSURs
- PMS data review & trend analysis
Clinical Strategy & Study Design
- Clinical Investigation Plans (CIP)
- Study design & protocol development
- Statistical plans & sample size calculations
Clinical Study Documentation
- Investigator Brochures (IB)
- Informed Consent Forms (ICF)
- eCRF design & study documentation package
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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