PLANREFERENCE OUTLINE

Medical Device Clinical Investigation Plan

Investigation plan under the device good clinical practice standard, which is not the drug one: risk analysis documented before the design, the operator treated as part of the intervention with training and learning curve controlled, controls named where blinding is impossible, device version traceability with a documented poolability assessment, and device deficiencies reported on potential rather than actual harm. Maps to ISO 14155:2026.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ISO 14155:2026
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

Device clinical investigations have their own good clinical practice standard, and reaching for the drug one is a scope error that survives a spot-check because both are real and both say GCP. The plan has to hold two things the drug framework does not: the operator as part of the intervention, and device versions changing while the investigation runs. Whether results across versions can be pooled is the sponsor’s determination.

What's Inside

✓Identification stating which standard is applied, deliberately rather than by inherited template habit
✓What the investigation must demonstrate, traced back to intended-use claims and to residual risk
✓Risk analysis performed and documented before the design, so the design answers something real
✓The operator as part of the intervention, with training, experience and learning curve controlled
✓Bias controls named where blinding is impossible, rather than blinding claimed and quietly abandoned
✓Device version traceability per subject, with a documented poolability assessment before results are combined
✓Device deficiency and adverse event definitions with their reporting routes and reporting timelines

How to Use It

1State the standard applied on the title page; the differences from drug GCP are structural, not stylistic.
2Document the risk analysis before the design — a design cannot be a response to residual risk if both are written together.
3Control and record operator training and prior experience, or device performance cannot be separated from operator skill.
4Name the bias controls you are using where blinding is impossible; silence here reads as no control at all.
5Record every device version used per subject and assess poolability before combining results across versions.
6Report device deficiencies on what could have happened, not only on what did; that clause catches the near miss.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Investigation Identification and Standard Applied
2What the Investigation Must Demonstrate
3Risk Analysis Preceding the Design
4The Operator as Part of the Intervention
5Blinding, Bias Control and Device Version Traceability
6Device Deficiencies and Adverse Events
REGULATORY CONTEXT

ISO 14155:2026 is the good clinical practice standard for clinical investigations of medical devices in human subjects, covering risk management, investigation planning, monitoring, and device deficiency and adverse event reporting. It is a different standard from ICH E6, which governs drug trials. It does not decide your endpoints, whether your device versions are poolable, or how much operator training is enough — those determinations sit with the sponsor and the investigator. The plan structure and guidance notes are SPEQ practitioner synthesis.

MAPPED STANDARDS
ISO 14155:2026
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