ISO 14155 compliance and requirements, for device studies that protect subjects and produce evidence reviewers accept.

What it is

What is ISO 14155 and what is it used for?

ISO 14155 is the international standard for good clinical practice in clinical investigations of medical devices carried out in human subjects. It is developed by ISO/TC 194, the committee for biological and clinical evaluation of medical devices. It covers how an investigation is designed, conducted, recorded and reported when it assesses a device's clinical performance, effectiveness and safety.

Its purpose is twofold. First, it protects the rights, safety and well-being of the people who take part. Second, it makes the investigation scientifically sound, so the clinical evidence it produces can be relied on. It also sets out the responsibilities of the sponsor and the principal investigator, and helps ethics committees, regulatory authorities and conformity assessment bodies judge an investigation consistently. It can be applied to post-market investigations and to software as a medical device where relevant; it does not apply to in vitro diagnostic devices.

Current edition. ISO 14155:2026, the fourth edition, was published on 23 March 2026 and withdrew ISO 14155:2020. ISO describes the changes as clarifications to clinical performance, informed consent, eligibility criteria, adverse event reporting and suspension of an investigation, and new or stronger requirements on residual risks, data monitoring committees, clinical events committees, implant cards, missing data, estimands, subject follow-up and risks from clinical procedures. ISO has also registered a new project, ISO/AWI 14155, that will in time replace the 2026 edition. There is no certificate, so there is no certification transition; the task is to bring procedures and live studies in line with the current text.

Who it is for

Who needs ISO 14155 compliance?

Any organisation that sponsors, runs or supports a clinical investigation of a medical device has a reason to work to ISO 14155. Sponsors come to Sterling from four starting points:

• A notified body or regulator reviews your clinical evidence. The investigation behind your technical documentation is judged on how it was planned, monitored and reported, and gaps in good clinical practice weaken the evidence itself.
• A hospital, ethics committee or investigator asks for it. Sites and ethics committees expect a sponsor to show a structured protocol, informed consent process, monitoring plan and safety reporting before a study begins.
• A distributor, licensing partner or acquirer checks your data. Due diligence on a device often starts with the clinical file, and a partner wants to know the studies will stand up to scrutiny.
• Your group runs studies across countries or through a contract research organisation. One set of sponsor procedures and clear oversight of outsourced tasks keeps every site working to the same practice.

The benefit is credible evidence and protected participants. It depends on how each investigation is run, not on a document on file.

Requirements

What are the main ISO 14155 requirements?

The requirements follow an investigation through its life, from ethics and design to reporting, and assign duties to the sponsor and the principal investigator. The list below is a plain-language map of the requirement areas ISO names for the 2026 edition; your procedures are checked against the full standard during the programme.

• Subject protection and ethics: put the rights, safety and well-being of subjects first, with ethics committee review and a sound informed consent process.
• Investigation planning: justify the design in a clinical investigation plan, set eligibility criteria and address residual risks and risks from clinical procedures.
• Statistical integrity: define estimands and plan how missing data will be handled before results are known.
• Conduct and oversight: monitor the investigation, use data monitoring and clinical events committees where warranted and keep subjects under follow-up.
• Safety reporting: record, assess and report adverse events to the requirements the 2026 edition strengthens.
• Suspension and ending an investigation: decide and handle a suspension, or an early or planned end, in a controlled way.
• Records and reporting: keep study documents and case data complete and accurate, and report results credibly, with implant cards where they apply.
• Sponsor and investigator responsibilities: define who does what, including oversight of work delegated to contract research organisations and sites.

Putting it into practice

How do you achieve ISO 14155 compliance and prove it?

Compliance is built into your sponsor processes once, then demonstrated study by study. There is no certification audit at the end: the proof is the investigation file, reviewed by the ethics committee, the regulator or the conformity assessment body that relies on your clinical evidence, and by your own audits.

1. 01
   Define the clinical programme and your role.List the current and planned investigations, the countries and sites involved, and which tasks you keep and which you delegate.
2. 02
   Gap assessment against ISO 14155:2026.Compare your procedures, templates and a sample of study files with the current edition, and agree actions, owners and dates.
3. 03
   Build the sponsor system.Procedures and templates for the investigation plan, consent, monitoring, safety reporting and close-out, linked to your ISO 13485 and ISO 14971 processes.
4. 04
   Train the team and oversee the sites.Train sponsor staff and brief investigators, qualify and oversee contract research organisations, and apply the procedures to live studies.
5. 05
   Audit internally and keep it current.Audit study files and sites, close findings with evidence and prepare for reviews by ethics committees, regulators and conformity assessment bodies.

Check the route before you sign. An offer of an "ISO 14155 certificate" for your organisation does not replace good clinical practice in each study, and no reviewer reads it in place of the investigation file. Where you need a certificate, it belongs to your ISO 13485 quality management system: ask for the certification body's accreditation and scope and verify them directly with the accreditation body, which is recognised under the Global ACI arrangement.

Cost

How much does ISO 14155 compliance cost?

Cost follows the size of your clinical programme rather than the length of the standard. A start-up preparing its first pivotal study needs a different scope from a manufacturer running several post-market investigations across countries. Every Sterling proposal shows each component and one all-inclusive proposal.

Timeline

How long does ISO 14155 compliance take?

The pace depends on whether a study is already running, how many procedures need writing or revising, and how quickly clinical staff and investigators can be trained. As an estimate, bringing sponsor procedures, templates and training in line with ISO 14155:2026 typically takes three to six months. Aligning a live study also depends on ethics committee timelines for any amended documents.

If a first patient date is fixed, tell us at the start. We plan backwards from it and say plainly what can be ready in time.

Your engagement

What your ISO 14155 engagement includes

Sterling does not certify, and no ISO 14155 certificate exists to be issued; where a certificate is needed, an accredited certification body audits your ISO 13485 system and makes that decision. Our work is to make good clinical practice routine in every study you sponsor, with the level of support you choose.

• Design™: guided support

  Your clinical team does the work, with Sterling's methodology, templates, reviews and workshops at each stage.

• Drive™: managed delivery

  An alternative to Design™: our consultants carry the programme with your owners, from gap assessment to internal audit.

• Sponsor procedures and templates

  Investigation plan, consent, monitoring, safety reporting and close-out, written for how your studies really run.

• Training for sponsor staff and sites

  Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Sustain™ after the procedures go live

  Study file audits, updates when the standard changes and support ahead of external reviews, and surveillance preparation after ISO 13485 certification.

• Automate™ with Effivity

  Documents, training records, audits, findings and actions in Effivity, included with the engagement at no additional cost.

Decisions on ISO 13485 certification remain with the independent, accredited certification body.

Often combined with

Standards organisations pair with ISO 14155

• 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
• ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• EU IVDR 2017/746EU IVDR compliance consulting for IVD manufacturers: performance evidence, QMS, traceability and post-market follow-up prepared for your notified body.
• EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
• FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.