Clinical Evaluation Review Services
Independent review support for medical device clinical evaluation documentation.
Accurate Assessments helps manufacturers, importers and UK Responsible Person clients identify gaps in clinical evaluation documentation before submission, registration or regulatory review.
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Practical review of your clinical evaluation file
We review clinical evaluation plans, reports, literature search methodology, equivalence arguments, post-market clinical follow-up links and the consistency between your CER, risk management file, PMS documentation and technical documentation.
Our approach is designed to highlight practical gaps and actions, not just provide generic comments.
Structured, clear and action-focused
We help you understand what is strong, what needs improvement and what may create regulatory questions.
Documentation check
We check whether the clinical evaluation documentation is complete, logically structured and aligned with the device claims and intended purpose.
Evidence review
We assess whether clinical data, literature, PMS and PMCF inputs support the stated safety and performance claims.
Gap report
You receive clear observations, risk-based priorities and recommended corrective actions for your technical documentation.
Clinical evaluation areas we can support
The service can be tailored depending on whether you need a light-touch review, a detailed gap assessment, or support preparing your documentation for UK or EU regulatory expectations.
Clinical Evaluation Report review
Assessment of CER structure, content, consistency and traceability to device claims.
Literature search strategy review
Review of search terms, databases, inclusion criteria, appraisal approach and justification.
Equivalence and clinical data review
Support identifying weaknesses in equivalence, data sufficiency and benefit-risk justification.
PMS and PMCF alignment
Review of how post-market evidence feeds into the clinical evaluation lifecycle.
Regulatory support with UKRP and technical documentation insight
Accurate Assessments combines UK Responsible Person experience with practical medical device regulatory knowledge, helping you address documentation issues before they become market access delays.
Clinical evaluation review FAQs
Do you write the full Clinical Evaluation Report?
We can support with review, gap assessment and improvement recommendations. If you need full CER writing, contact us so we can confirm the scope and device details.
Can you review an existing CER before submission?
Yes. We can review an existing CER and supporting evidence to identify gaps, inconsistencies and areas that may need strengthening.
Can you support UK Responsible Person clients?
Yes. We can support overseas manufacturers and UK Responsible Person arrangements where clinical evidence review is needed as part of technical documentation due diligence.
Need a clinical evaluation review?
Send us a short summary of your device, intended purpose and current documentation status. We will advise on the most suitable review route.
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