Clinical Evaluation Report (CER) writing is critical for demonstrating the safety, performance, and clinical benefit of medical devices in line with EU MDR and global regulatory expectations.
Syrma Johari MedTech supports this through end-to-end CER development, delivered by a team of qualified medical writers with strong clinical, scientific, and regulatory expertise. From literature search and data analysis to clinical evaluation and documentation aligned with regulatory guidelines, SJML helps OEMs build defensible CERs that support successful submissions and sustained compliance.
Clinical evaluations rely on structured literature review and scientific data analysis. We conduct systematic searches across globally recognized medical and regulatory databases.
PubMed / MEDLINE, Embase, Google Scholar, Cochrane Library, ClinicalTrials.gov, and EUDAMED
Search strategy & keywords, inclusion/exclusion criteria, article screening, critical appraisal, data extraction, and clinical evidence synthesis with benefit–risk evaluation.
This ensures literature reviews meet regulatory expectations during notified body assessments.
Our approach follows internationally recognized regulatory frameworks including MEDDEV 2.7/1 Rev 4, EU MDR Annex XIV, ISO 14155, and MDCG guidance documents.
We define the clinical evaluation approach, equivalence strategy, and evidence requirements for the device or IVD.
Deliverables
Systematic literature searches across scientific databases to identify relevant clinical evidence.
Deliverables
Scientific review and critical appraisal of clinical studies, real-world evidence, and post-market data.
Deliverables
Compilation of CER or PER documents demonstrating clinical safety, performance, and benefit-risk profile.
Deliverables
Preparation of SSCP and integration of clinical evidence into regulatory submissions and technical documentation.
Deliverables
Plan, build, and maintain compliant clinical evidence across global markets.
A CER is a regulatory document required under EU MDR that evaluates clinical data to demonstrate a device’s safety, performance, and benefit-risk profile.
The CEP defines how clinical evidence will be generated and evaluated, including literature search strategy, equivalence methodology, and clinical data sources.
Summary of Safety and Clinical Performance (SSCP) is a document required under EU MDR that provides clear clinical information about device safety and performance for healthcare professionals and patients.
Clinical evaluations typically use PubMed, Embase, Google Scholar, and Cochrane Library, along with regulatory and clinical trial databases.
CER updates depend on device classification and regulatory requirements. Higher-risk devices typically require annual or periodic updates aligned with PMS and PMCF activities.
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