Clinical & Regulatory Consulting for Medical Devices & MedTech
CER & PMS Updates starting at $4,666
Our Clinical Strategy & Support Services
PMCF Survey Execution
- Planning and executing post-market clinical follow-up surveys
- Ensuring compliance with EU MDR requirements
- Analyzing survey data for clinical insights
Clinical Evaluation Plan (CEP) Services
- Reviewing current Clinical Evaluation Plans
- Updating plans according to new regulations
- Providing remediation strategies if gaps are found
Clinical Literature Review
- Performing systematic literature searches
- Summarizing relevant findings
- Ensuring evidence supports product claims
Clinical Evaluation Report (CER) Services
- Drafting and Reviewing CERs
- Updating CERs with new data
- Addressing any gaps or compliance issues
Clinical Strategy & Support
- Developing clinical strategies for product launches
- Supporting regulatory submissions
- Providing guidance on clinical trial design
Post-Market Surveillance (PMS) Strategy & Support
- Planning Post-Market Surveillance activities
- Monitoring product performance
- Advising on risk mitigation strategies
Medical Device Regulatory Strategy & Support Services
We provide various regulatory strategy and support services to help you navigate compliance with confidence.
Regulatory Support
EU MDR Technical File Creation & Management
Gap Analysis (MDD to MDR 745/2017)
IFU and Label Management
Regulatory Operations Support
Market Approval Support
FAQ's
Clinical and regulatory consulting covers the strategy and documentation needed to bring a medical device or diagnostic to market and keep it compliant afterward — including EU MDR and IVDR strategy, clinical evaluation, PMCF/PMPF surveys, post-market surveillance (PMS) planning, PSUR preparation, vigilance and incident reporting, and QMS support.
PMCF (Post-Market Clinical Follow-up) is the ongoing collection of real-world data on a device's performance after it's launched, required under EU MDR Annex XIV. Manufacturers need it to confirm continued safety and performance, support CE marking maintenance, and catch issues that pre-market trials couldn't fully anticipate.
Cetas Healthcare supports EU MDR and IVDR compliance by designing and executing PMCF/PMPF plans and studies aligned to MDCG guidance, developing PMS plans and PSURs, and providing regulatory strategy guidance so manufacturers can navigate conformity assessment and post-market obligations without unnecessary delays.
PMS (Post-Market Surveillance) is the overarching plan for monitoring a device after launch; PMCF is a specific, ongoing clinical data-collection activity within that plan; and a PSUR (Periodic Safety Update Report) is the periodic summary report that consolidates surveillance findings, trend analysis, and benefit-risk conclusions for regulators.
Yes. PMCF surveys are widely used for legacy devices that lack extensive pre-market clinical data, gathering real-world evidence on long-term performance and safety to help manufacturers demonstrate ongoing compliance and maintain CE marking under current EU MDR requirements.
PMCF and PMPF evidence is typically generated through surveys, observational studies, registry data, and literature surveillance, with study design following Annex XIV and relevant MDCG guidance — including statistical analysis and sample size planning — so the resulting data holds up to regulatory scrutiny.
Timelines vary with device class, sample size requirements, and geography, but PMCF survey projects have been completed in as little as 8 weeks for a defined scope, gathering several hundred respondent data points across multiple regions when the study design and target population are clearly scoped upfront.
Yes. While EU MDR and IVDR compliance is a core focus, clinical and regulatory consulting also addresses FDA and other global regulatory requirements, helping MedTech companies coordinate evidence generation and documentation across multiple markets rather than treating each region separately.
Regulatory affairs, quality, and clinical teams at medical device and IVD companies typically bring in outside clinical and regulatory consulting when facing an EU MDR/IVDR transition, a PMCF/PMS obligation, a legacy device compliance gap, or when internal teams need additional capacity around a submission deadline.
Contact the Cetas Healthcare team with your device classification, the regulation you need to comply with (EU MDR, IVDR, FDA, etc.), and your timeline, and they'll help scope the right combination of regulatory strategy, PMCF/PMS planning, and evidence generation.
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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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