Clinical Evaluation: the evidence that supports your registration.
We prepare your device's Clinical Evaluation Plan and Report (CER), bringing together literature, clinical data and equivalence analysis to demonstrate safety and performance under MDR 2017/745, MEDDEV 2.7/1 Rev.4 and ANVISA requirements.
What we deliver
We build the clinical evidence base that supports registration and CE marking.
Clinical Evaluation Plan (CEP) and definition of the state of the art.
Systematic literature review and critical appraisal of studies.
Analysis of clinical equivalence and post-market data.
A structured, traceable Clinical Evaluation Report (CER).
Integration with post-market surveillance (PMS/PMCF).
Deliverables
What you receive
A Clinical Evaluation Plan (CEP).
A complete Clinical Evaluation Report (CER).
A literature review protocol and evidence matrix.
Recommendations for post-market clinical follow-up (PMCF).
References
Reference standards
- MDR 2017/745 and MEDDEV 2.7/1 Rev.4 - clinical evaluation in the European Union.
- ISO 14155 - good clinical practice for device investigations.
- ANVISA clinical evidence requirements (RDC 751/2022 and related requirements).
FAQ
Frequently asked questions
Let's talk
Need to demonstrate your device's clinical safety and performance?
We prepare your CER with regulatory rigour.
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