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Navigating EU MDR or IVDR requirements? Elexes provides clinical evaluation consulting services in a flexible manner, meeting requests from medical device manufacturers in rigorous regulatory settings. Your Clinical Evaluation Report (CER) can be prepared by our experts for the legacy device, or we can support submissions for new products. In all cases, our team will ensure your documentation is accurate, scientifically sound, and compliant with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV.
Our clinical evaluation consultants help reduce time to market, avoid costly rejections, and ensure notified body acceptance on the first attempt.
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The Clinical evaluation is a mandatory component under both the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It involves a systematic review and assessment of clinical data to prove device safety and performance.
As a leading clinical evaluation consulting firm, Elexes assists with:
⦿ Literature review and analysis
⦿ Equivalence justification
⦿ Clinical evidence gap analysis
⦿ PMCF (Post-Market Clinical Follow-up) planning
⦿ Compliance with MDCG and MEDDEV guidance
We support all device risk classes from Class I to III and diagnostic devices. If your CERs are outdated, incomplete, or not aligned with current requirements, we can fix them.
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Whether you're preparing a Clinical Evaluation Plan (CEP) or a CER, our clinical evaluation consultant work closely with your team to ensure end-to-end readiness. Our medical writers, regulatory experts, and clinicians bring in-depth knowledge of device technologies, global standards, and Notified Body preferences.
We also provide CER remediation support to align with Annex XIV Part A of the EU MDR, minimizing the risk of audit nonconformities or market withdrawal.
Visual clarity helps teams stay aligned. These infographics break down the key components and timeline of CER development under EU MDR.
A clinical evaluation consultant helps medical device companies compile compliant clinical evidence per EU MDR/IVDR regulations, including CER writing and strategy.
It proves your device’s safety and performance through scientific literature, clinical data, and post-market evidence, as required by MDR Annex XIV.
Yes. We review, update, and rewrite existing Clinical Evaluation Reports to meet latest MDR standards and Notified Body expectations.
Absolutely. We support clinical evaluation reports for both medical devices and in-vitro diagnostics, including IVD performance evaluations.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
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