This Clinical Evaluation & Clinical Investigation Procedure complies with EU MDR 2017/745, ISO 14155, and ISO 13485:2016. Delivered in editable Word format, it defines requirements for planning, conducting, and documenting clinical evaluations and clinical investigations. Digital delivery within 24 business hours.
This procedure outlines clinical evaluation planning, literature review, clinical data appraisal, PMCF integration, clinical investigation design, ethics approvals, monitoring, reporting, and documentation requirements. Included with Informed Consent Form (ICF) Template and further information. It ensures conformity with EU MDR Annex XIV and ISO 14155. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.