Medical Device Clinical Investigation Report | ISO 14155:2026

Prepare the final account of a medical device clinical investigation with an editable Clinical Investigation Report. The document provides a structure for device and site details, study design, methods, participants, results, deviations, adverse events, analysis and conclusions.

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Supplied as one editable Microsoft Word document in a digital download.

Study results, deviations and conclusions

The report also addresses deviations, adverse events, analysis, limitations and conclusions. Its structure helps connect reported results to the approved investigation plan and source records. It is intended to support ISO 14155:2026 and MDR (EU) 2017/745 requirements.

Related documents for this workflow

• Define the planned objectives, methods and endpoints. Medical Device Clinical Investigation Plan (CIP) | ISO 14155:2026.

• Manage the broader investigation process and related records. Clinical Investigation Procedure.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Clinical Investigation Documents: Plan, Investigator Brochure and Report for workflow guidance, a checklist and common mistakes.