CLINICAL EVALUATION GAP ANALYSIS
Identify clinical evidence gaps before your Notified Body does
Need an independent view of your CER before a submission or audit?
£3,250 | Written diagnostic within five working days
Not sure yet? Book a free 30-minute Consultation →
A structured review of your clinical evidence, documentation, and remediation priorities, ahead of submission or audit
A Clinical Evaluation Gap Analysis is a structured review of your clinical evidence and associated documentation, designed for manufacturers preparing for a Notified Body submission, a surveillance audit, or both.
We assess your existing clinical data, literature, and technical documentation against MDR Article 61, Annex XIV, and current MDCG guidance, identify gaps across seven review dimensions, and provide a prioritised action plan to address them before review begins.