Services

Scope of Services

Supporting regulatory and clinical teams with structured, regulator-ready documentation across pre-market, clinical and post-market phases.

Clinical Evaluation & Regulatory Documentation

Clinical Evaluation Reports (CER) – drafting, remediation and updates
Clinical Evaluation Plans (CEP)
State-of-the-art and clinical evidence justification
Clinical sections of EU Technical Documentation
MDR transition and remediation documentation
Notified body response support

Clinical Trial & Study Documentation

Clinical Investigation Plan (CIP) documentation support
Investigator Brochure (IB) documentation support
Ethics submission documentation
Informed Consent Form (ICF) review and refinement
Regulatory authority submission documentation
Trial master file (TMF) documentation support
Clinical study report (CSR) drafting support

Regulatory Lifecycle Coverage

Documentation support aligned with:
Initial CE marking preparation
Clinical investigation preparation and documentation
EU MDR transition
Post-market clinical follow-up (PMCF) integration
Notified body findings and remediation
Ongoing lifecycle documentation maintenance

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