Bringing a medical device to market requires more than innovation—it demands robust clinical evidence that demonstrates safety, performance, and compliance. A well-prepared Clinical Evaluation Report (CER) is central to this process, helping manufacturers align with regulatory requirements, maintain market access, and strengthen post-market surveillance strategies.
Our team specializes in clinical evaluation report writing for medical device companies seeking compliance with both U.S. FDA and European MDR expectations. Each CER we develop integrates the latest clinical investigation data, scientific literature, post market surveillance, risk management and performance/ safety evidence to ensure a complete and clearly documented evaluation.
A professionally written CER demonstrates that your device’s benefits outweigh the risks while meeting current regulatory expectations. Our expert writers—experienced in clinical research, risk assessment, and regulatory documentation—craft detailed, defensible reports designed to withstand scrutiny from regulatory authorities.
Successful compliance starts with a strong Clinical Evaluation Plan (CEP). Our specialists design a clear, structured CEP that defines the methodology for literature searches, appraisal criteria, equivalence assessment, and data interpretation. This plan forms the foundation for effective clinical evaluation plan & report writing that conforms to current MDR and MEDDEV 2.7/1 Rev. 4 guidance.
We align every report with your risk management documentation, ensuring all potential hazards, harms evaluation outcomes, and benefit-risk assessments are supported by objective evidence. By maintaining clear links between CEP, CER, and Risk Management files, we help your regulatory team demonstrate device safety and performance through a transparent and traceable process.
Establishing the scientific and clinical context for your device requires a thorough understanding of the available technology and alternative therapies. Our state of art reports summarize the current clinical landscape, benchmark comparable devices, and identify knowledge gaps that impact your product’s clinical positioning.
This evidence-driven approach strengthens your CER’s rationale, ensuring that your device stands up to regulatory scrutiny while highlighting its unique clinical value.
Whether you are preparing for EU market entry, MDR transition, or both, high-quality clinical documentation is critical. Our expertise extends beyond report writing — we bring strategic insights that blend regulatory compliance with practical, business-oriented solutions. We support companies through CE Marking consulting for medical devices, helping align documentation with evolving European MDR expectations while maintaining consistency with FDA submissions.
With our structured process, medical device manufacturers can improve time to approval, reduce queries from notified bodies, and maintain compliance readiness across regulatory jurisdictions.
From low-risk Class I devices to complex, high-risk implants and digital health technologies, we tailor each CER to the device’s intended use, risk classification, and available clinical evidence. Our approach combines scientific rigor with precise regulatory alignment—balancing technical depth with clear narratives for regulatory reviewers and quality teams alike.
Partnering with experienced CER professionals ensures that your report not only meets compliance requirements but also showcases the clinical and economic value of your innovation.
At PM Consultants we are a group of dedicated medical writers, regulatory affairs professionals, clinical researchers, and quality
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