Medical Devices
Leveraging PMCF Surveys to Solve Real-World Data Challenges for Legacy Medical Devices
Legacy devices face major clinical evidence gaps. PMCF surveys offer the...
Blogs
Regulatory
A Complete Guide to Performing Conformity Assessment Under EU MDR 2017/745
EU MDR transforms how devices enter the European market. This guide explains...
IVD Regulation
Ensuring Safety & Compliance: A Guide to Conducting PMPF Surveys for IVD Products
IVDR requires continuous real-world performance evidence. PMPF surveys help detect risks, validate...
Global Markets
How EU MDR Certification Accelerates Global Market Expansion
EU MDR certification strengthens global credibility, accelerates international approvals, and...
Orthopaedic Devices
Global Regulatory Changes in Orthopaedic Device Manufacturing
Discover how orthopaedic device manufacturers can meet EU MDR requirements using clinical t...
Clinical
Post-Market Clinical Follow-up
Under the EU MDR (MDR 2017/745), PMCF is a required element of the post-market surveillanc s...
Clinical
Understanding Data Gaps in Orthopedic CERs
In orthopedic devices, Clinical Evaluation Reports (CERs) often face data gaps that can impact...
Clinical
Integrating PMCF Data into Clinical Evaluation Reports
Integrating PMCF data into Clinical Evaluation Reports supports continuous safety, performance...
Clinical
RWE vs. Clinical Trials
Learn how integrating PMCF data into Clinical Evaluation Reports supports continuous safety, performance, and regulatory compliance throughout the device lifecycle.
Medical Devices
Your Legacy Device Passed MDD. But Will It Pass MDR?
Understand why legacy devices that passed under MDD may still face clinical evidence gaps under MDR
Medical Devices
The SSCP Is Becoming Your File to Manage, and That Matters More Than It Sounds
Understand how MDCG 2026-4 changes SSCP management in EUDAMED and why manufacturers ...
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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