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Clinical Evaluation & CER
Clinical Evidence & Benefit-Risk Strategy
Clinical evidence should support intended purpose, safety, performance and benefit-risk. The depth of evidence expected depends on device risk, novelty, claims, technology, available comparable evidence and the Australian application pathway.
Our Clinical Evidence Support Includes
Clinical evidence gap assessment against TGA Clinical Evidence Guidelines
Systematic clinical literature search and appraisal strategy
Clinical Evaluation Report (CER) drafting, updating, and remediation
Comparable and equivalent device technical and clinical equivalence justification
Clinical investigation protocol strategy and regulatory oversight where primary data is needed
Clinical claim substantiation and marketing claim alignment
Benefit-risk determination and residual clinical risk quantification (ISO 14971)
Post-market clinical follow-up (PMCF) and registry evidence integration
Preparation for TGA application audit questions on clinical data and literature sufficiency
NKB Evidence-Sufficiency Test:
We do not ask only whether a clinical evaluation exists. We ask whether the evidence is sufficient for the exact intended purpose, risk profile and claims of the Australian device — and whether it can be defended if TGA selects the application for audit.
Substantiate Your Device Claims with Robust Clinical Data
Our clinical regulatory writers compile CERs, justify clinical equivalence, and prepare clinical audit defense packages.