Creating a high quality, compliant Clinical Evaluation Report under the EU MDR is demanding work, from evaluating the available clinical evidence through to demonstrating regulatory alignment. It is also one of the most common causes of Notified Body questions.
Compliance Management Solutions delivers CERs that stand up to scrutiny and support faster market access.
What our CER services cover
- End to end CER authorship, from planning through to final submission
- Comprehensive literature review and gap analysis
- Assessment of device equivalence and clinical data
- Critical appraisal and statistical evaluation
- Integration of post-market surveillance, PMCF and risk management data
- Full compliance with MDCG guidance and Annex XIV of the MDR
Reports are authored by experienced medical writers and regulatory specialists. To discuss a clinical evaluation for your device, please contact our regulatory team.