Clinical & Regulatory Planning
Evidence-Driven Planning for Safe, Compliant, and Successful Medical Devices
Our Services
CEP & CER Support
Develop and remediate CEPs and CERs fully aligned with MDR/MEDDEV expectations. We support SOTA development, benefit–risk analysis, literature appraisal, claims mapping, and NB responses—delivering audit-ready, regulation-compliant documentation.
Systematic Literature Review (SLR)
End-to-end PRISMA-aligned literature reviews for CER, PMS, PMCF, and Risk Management. We conduct clinical, SOTA, safety, and benchmark reviews using robust search strategies and transparent, defensible methodologies.
PMS Support
Complete PMS planning and reporting under EU MDR Articles 83–86: PMS Plans, PMSRs/PSURs, vigilance trend analysis, clinical review, and CER–RMF linkage. We prepare NB-ready PMS documentation tailored to device class and regulatory expectations.
PMCF Support (Rank 4 & 8 Surveys)
Design and execute PMCF activities including PMCF Plans, Evaluation Reports, Rank 4/8 surveys, patient-experience studies, and device-specific follow-ups. We ensure full compliance with MDR Annex XIV Part B and MDCG guidance.
Clinical Strategy
Develop strategic, regulation-aligned clinical frameworks that support safe, compliant evidence generation across the lifecycle. Our services include early planning, feasibility assessment, study design, and preparation of core clinical investigation materials.
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Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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