Evidence Instead of Opinions.
The Clinical Evaluation Report (CER) is the heart of MDR compliance. We write rigorous, audit-proof CERs based on systematic literature reviews.
MDR Compliance
Aligned with MEDDEV 2.7/1 Rev 4 and MDR Article 61. We ensure your SOTA analysis is defensible.
PhD Writers
Our medical writers hold PhDs or MDs. They understand clinical data and can effectively argue equivalence.
Living Document
We set up a schedule for updates. A CER is never 'done'; it must be updated with PMS data annually.
Science Meets Regulation.
Systematic Search
We use reproducible search protocols (Embase, Medline) to prevent 'Bias' findings from auditors.
Integrated Risk
We cross-check clinical risks against your Risk Management File (ISO 14971) to ensure consistency.
Clear Conclusion
We don't just dump data. We synthesize it into a clear Benefit-Risk determination.
CER Writing Process
CEP & Scope
Draft the Clinical Evaluation Plan (CEP) and define State of the Art (SOTA).
Literature Review
Execute search protocols. Screen and appraise scientific literature.
Report & Approval
Compile safety/performance data, analyze PMCF needs, and finalize the CER.
Clinical Documents
Frequently Asked Questions
How often do we update?
Class III/Implantable: Annually. Others: As defined (usually 2-3 years) or when PMS data signals a risk.
Do you handle equivalence?
Yes, we perform the detailed technical, biological, and clinical comparison for claimed equivalents.
What about Literature Search?
We have access to major medical databases (PubMed, Embase, etc.) included in the service.