Clinical Investigations
ISO 14155: Clinical Investigation of Medical Devices in Human Subjects
ISO 14155 sets good clinical practice for clinical investigations of medical devices in human subjects. It protects the rights, safety and well-being of subjects, supports the scientific conduct of the investigation and the credibility of its results, and defines the responsibilities of sponsors and principal investigators.
At a Glance
- Standard
- ISO 14155
- Subject
- Clinical Investigation of Medical Devices in Human Subjects
- Group
- Clinical Investigations
- Industries
- 3 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The standard follows the life of a clinical investigation: planning and design, the clinical investigation plan, the investigator's brochure, ethics committee review, informed consent, site selection and training, monitoring, data management, safety reporting of adverse events and device deficiencies, and the final clinical investigation report. Risk management of the investigational device and of the investigation itself runs throughout.
It applies to clinical investigations that assess the clinical performance, effectiveness or safety of a device, whether they support a regulatory submission or take place after the device is on the market. Some requirements scale with the type of investigation and the risk it poses to subjects.
In the US, investigational device studies are governed by FDA regulations, including the investigational device exemption rules in 21 CFR Part 812, and FDA's Bioresearch Monitoring (BIMO) program inspects sponsors, investigators and IRBs. ISO 14155 lines up with much of that, and sponsors running multinational studies often build their procedures on it, but it doesn't replace the regulations of any jurisdiction.
Who It Applies To
- Sponsors running device clinical investigations, including startups
- Clinical sites and principal investigators
- Contract research organizations supporting device studies
- Manufacturers running post-market clinical studies
- Firms preparing for a BIMO inspection or a review of their clinical data
What Auditors Check
Clinical Investigation Plan
An approved plan and its amendments, with version control showing which version applied at each site and when.
Informed Consent
Signed, current consent forms for each subject, obtained before any study procedures began.
Ethics and Regulatory Approvals
Ethics committee or IRB approvals and regulatory authorizations in place before enrollment started.
Monitoring
A monitoring plan and visit reports showing source data verification and follow-up of the issues found.
Safety Reporting
Adverse events and device deficiencies captured, assessed and reported to the required parties on time.
Device Accountability
Records of investigational device shipment, receipt, use, return and disposition that reconcile.
Data Traceability
Data traceable from source documents to case report forms and into the final report.
Related Services
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
PMA Pre-Approval Inspection Preparation
Getting Class III manufacturers ready for the facility inspection that accompanies PMA review.
Industry Guides That Reference ISO 14155
Questions
Does following ISO 14155 satisfy FDA's requirements for device studies?
Not on its own. US device studies must meet FDA's regulations, including the investigational device exemption rules in 21 CFR Part 812 and FDA's informed consent and IRB rules, and BIMO inspections check against those. Procedures built on ISO 14155 are a strong foundation, but they still need to be mapped to the US requirements.
Who is responsible for monitoring, the sponsor or the site?
The sponsor is responsible for monitoring the investigation, though it can delegate tasks to a contract research organization. The principal investigator is responsible for conducting the study at the site according to the plan and for protecting subjects. Auditors expect each party's responsibilities to be written down and followed.
Where do sponsor inspections tend to find problems?
Typical problem areas include inadequate monitoring, incomplete device accountability, protocol deviations that weren't assessed, and safety events reported late or inconsistently. These are record problems as much as conduct problems, which is why a document review before an inspection is worth doing.
Does ISO 14155 apply to post-market studies?
It can. The standard covers clinical investigations across the device life cycle, including post-market investigations, with some requirements scaled to the type of study. Whether a particular post-market activity counts as a clinical investigation depends on its design and the regulations that apply.
ISO 14155
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