Medical Device Clinical Investigation Plan (CIP) | ISO 14155:2026

Document a medical device clinical investigation before it begins with this editable 28-page Clinical Investigation Plan (CIP). It helps sponsors and investigators define the device, rationale, objectives, endpoints, subject selection, visits and follow-up, with prompts for monitoring, data handling, safety and termination decisions.

Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.

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

Prospective study planning and records

Prompts also address monitoring, data handling, safety events, termination criteria and care after the investigation. The approved plan then provides a reference for assessing deviations and final results. It is intended to support ISO 14155:2026 and MDR (EU) 2017/745 requirements.

Related documents for this workflow

• Manage planning, conduct, monitoring and close-out across the investigation. Clinical Investigation Procedure.

• Present and analyze the final study results. Medical Device Clinical Investigation Report | ISO 14155:2026.

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.