IEC 62366-1 · Usability engineering for medical devices
IEC 62366-1 compliance for devices people can use safely.
Show that the people who use your device can operate it without harm, with usability work that your risk management file, your auditors and your regulators can follow. Sterling's expert and experienced consultants set up the usability engineering process with your design team and help you build the evidence behind it. There is no IEC 62366-1 certificate to chase; what matters is the file. We help our clients put it into practice and prove it.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced medical device quality and risk consultants, working across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify, and there is no IEC 62366-1 certificate to issue
8,100+ client engagements in 60+ countries.
Why clients choose Sterling
What it is
What is IEC 62366-1 and what is it used for?
IEC 62366-1 is the international standard for applying usability engineering, also called human factors engineering, to medical devices. It sets out a process by which a manufacturer analyses, specifies, develops and evaluates the usability of a device as that usability affects safety. The aim is practical: find where interaction with the device could lead to harm, and design that risk down before release.
The process covers normal use, which the standard defines as correct use together with use errors, and lets the manufacturer assess and reduce the risks of both. Abnormal use is treated differently: the process can help identify it, but does not assess or mitigate its risks. It is written to work hand in hand with ISO 14971 risk management for the safety-related parts of the user interface.
Current edition. IEC 62366-1:2015, published in February 2015, replaced IEC 62366:2007 and its 2014 amendment. Amendment 1 followed in 2020, and IEC publishes the combined text as consolidated edition 1.1 of June 2020, which also takes in the 2016 corrigendum. ISO lists the standard as confirmed in June 2021, and IEC shows a stability date of 2028; no new edition is announced. Its companion guidance, IEC TR 62366-2:2016, is under revision, with a technical specification in development and no date announced.
Who it is for
Who needs IEC 62366-1 compliance?
Any manufacturer whose device has a user interface that people touch, read, hear or operate has a stake in IEC 62366-1: controls, displays, alarms, software screens, packaging and instructions for use all shape how a device is used. Manufacturers come to Sterling from four starting points:
- A regulatory submission or notified body review is ahead. The technical documentation needs usability evidence that links to the risk file, and the team is unsure whether what exists will stand up.
- A customer or distribution partner asks for usability evidence. Some OEM buyers, hospital procurement teams and distributors ask how use error was considered before they list or supply a device.
- A new device or a redesigned interface is in development. Starting the process early is far cheaper than retrofitting evaluations after the design is frozen.
- A group standard has to cover several sites or product lines. Different design teams run usability work in different ways, and the group needs one process that every file follows.
Requirements
What are the main IEC 62366-1 requirements?
IEC 62366-1 is a process standard, not a management system standard. Its scope names four activities the manufacturer carries out on the device's user interface, and sets boundaries on the kinds of use it addresses. The list below is a plain-language map at that level; the detailed requirements are checked against the current consolidated edition, one requirement at a time, during the programme.
- Analyse: understand who uses the device, for what purpose, in which environments, and which parts of the interface matter for safety.
- Specify: turn that analysis into a documented user interface specification that design can be verified against.
- Develop: design and build the user interface, testing ideas with representative users while changes are still affordable.
- Evaluate: confirm with evidence that the finished interface can be used safely by the intended users in the intended conditions.
- Normal use: assess and reduce the risks of both correct use and use errors, not only the risks of the device working as designed.
- Abnormal use: identify it where it can be foreseen; the standard does not ask the process to assess or mitigate its risks.
- Link to risk management: feed use-related hazards into the ISO 14971 process and carry its risk control decisions back into the design.
What does useful IEC 62366-1 evidence look like?
Evidence lives in the usability engineering file: a description of users, uses and environments, the safety-related interface characteristics and the use errors considered, the user interface specification, records of evaluations carried out during design, the final evaluation with its method, participants and results, and the trace from each use-related hazard to the ISO 14971 file. We help you keep only the records that prove something, and they sit in Effivity as the design progresses rather than being assembled after it.
Getting compliant
How do you become IEC 62366-1 compliant?
There is no certificate at the end of the route. The outcome is a usability engineering process that your design teams follow and a file for each device that your auditors, notified body or regulators can read. Sterling helps you build both; any decision about your device remains with those bodies.
- 01Define what the process must cover.Confirm the device families, their users and settings, the target markets, the design stage each device is at and the submissions or audits ahead.
- 02Gap analysis: compare current usability work with IEC 62366-1.Review procedures, design records, existing evaluations and the risk file, keep what holds up and agree actions, owners and dates.
- 03Set up the process and the plan.Write a usability engineering procedure that fits your design control, with templates, responsibilities and the hand-offs to the ISO 14971 process.
- 04Evaluate the user interface with real users.Plan and run evaluations during design, then the final evaluation of the finished interface, with representative users, realistic tasks and recorded results.
- 05Complete the file and keep it current.Close the trace to the risk file, review the evidence internally, and update it when design changes, complaints or field data raise a new use-related question.
Check the route before you sign. Because no IEC 62366-1 certificate exists for an organisation to hold, treat an offer of one as a warning sign. If a document is presented as proof of conformity, ask who issued it, under which accreditation, what exactly was examined, and verify the answers with the accreditation body concerned. The certification buyer's checklist
Cost
How much does IEC 62366-1 compliance cost?
There is no standard price: a single-use device with a simple interface needs far less work than connected equipment with software screens, alarms and several user groups. What Sterling offers is a proposal in which each component is visible and nothing is added later.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Current maturity, the number of device families, the complexity of the interfaces, the markets and how much of the work your team carries (Design™ or Drive™) |
| Independent assessment | There is no IEC 62366-1 certificate. Any review of the file happens within the audits, test programmes or submissions you already face, whose fees remain with those bodies |
| Internal resources | Design, software and regulatory time, recruiting representative users, test facilities and any interface changes the evaluations call for |
| Software and learning | Included in a Sterling engagement: Effivity for the process and the files, and Sterling Academy access for your people, with users, courses and access period confirmed in the proposal |
| Continued support | File updates after design changes, new markets and post-market findings, internal audits and refresher learning under Sustain™ |
What moves the price
- Number of devices and how different their users and settings are
- How far into design each device is when the work starts
- Whether any usability evaluations already exist and can be reused
- The number and type of evaluations needed, and who runs them
- Languages, markets and the submission timetable
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, in writing
- Third-party costs such as evaluation facilities identified separately
- Effivity, training and Academy access itemised at no additional cost
- Payment milestones tied to deliverables, not to the calendar
- One all-inclusive proposal. No surprises, ever
Timeline
How long does IEC 62366-1 compliance take?
Timing depends on where each device sits in its design life, how quickly representative users can be recruited, how many design changes the evaluations trigger and how soon your team can review the results. Setting up the process and building the file for an agreed device family typically takes three to six months.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Access to design records, the risk file, complaint data and the engineers who know the device |
| Process and plan | Agreement on responsibilities, templates and how usability fits your design control |
| Evaluations | Recruiting participants, preparing realistic tasks and settings, and making the changes the results call for |
| File completion and review | Closing the trace to the risk file, internal review and the date of the next audit or submission |
If a submission date is fixed, tell us at the start. A final evaluation cannot be scheduled accurately until the interface it tests is stable.
Your engagement
What your IEC 62366-1 engagement includes
Your engagement runs on Sterling OS™. You choose the level of support: Design™, where our consultants guide your team as it builds the process and files itself, or Drive™, where we manage the work and your engineers contribute their knowledge of the device. Either way, Automate™ puts the work in Effivity from the first workshop, and Sustain™ keeps the files current after the first device is complete.
Scope, gap analysis and plan
Device families, markets, owners and dates agreed before any work starts.
Usability engineering procedure
Written to fit your design control and linked to the ISO 14971 process, on Sterling's own templates.
Effivity ISO & GRC software
Plans, evaluations and traces kept in Effivity, included with the engagement at no additional cost.
Training for everyone
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.
Evaluation planning and review
Help to plan evaluations, choose participants and tasks, and read the results against the risk file.
File readiness
An internal review of each usability engineering file before an audit, submission or partner request.
Sterling does not certify, test or approve devices, and issues no IEC 62366-1 certificate; decisions about your device remain with your regulators, notified body and auditors.
Often combined with
Standards organisations pair with IEC 62366-1
- 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.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of IEC 62366-1.
Every Sterling IEC 62366-1 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so the procedure, plans, evaluation records, design changes, risk links, training records and internal audits are held together and kept current as each device develops. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Users, uses and environments
User groups, intended uses and settings recorded per device family, so every later decision refers back to the same description.
User interface specification
Controlled versions with approvals, linked to the design inputs they come from and the verification that tests them.
Design changes and their reasons
Each interface change logged with the finding that prompted it, so the file explains why the design looks the way it does.
Evaluation plans and results
Plans, participant profiles, tasks, observations and conclusions held as records, with actions tracked until they close.
Use errors and their controls
Each use error considered, the harm it could lead to and the control chosen, reviewed whenever the design or the evidence changes.
Trace to the ISO 14971 file
Use-related hazards linked to the risk register, so a change on one side shows up on the other instead of drifting apart.
The usability engineering file
Plans, specifications, evaluations and traces gathered per device, ready for an auditor, a reviewer or a partner request.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how your design teams work, without code, and connected to complaints and post-market data.
What this means at the audit
When an auditor or reviewer asks how a use error was found, what was done about it and how you know the control works, the answer is a chain of linked records in Effivity rather than a search through shared drives. After the first device, Sustain™ runs in the same workspace, so a design change or a complaint about use reaches the file straight away.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Existing design and evaluation records migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, ISMS and more when you integrate other standards
Sterling Academy · medical device e-learning
Help the whole device team understand use-related risk.
Sterling Academy offers e-learning for the people who design, test, document and support medical devices: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential Sterling Academy course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for design, regulatory, service and support staff
- Practitioner learning for the people who own the process and the files
- Internal auditor training, as applicable to your standard, as part of the engagement
- Training records that show competence to an auditor
- New team members trained as they join
Keep exploring
Explore more about IEC 62366-1
IEC 62366-1 resources
Services for IEC 62366-1
Why Sterling
Why work with Sterling on IEC 62366-1?
Usability work fails when it is treated as a test at the end instead of a thread through design. Sterling connects it to the systems medical device manufacturers already run, the quality system and the risk management process, so one team, one set of records and one plan carry all three.
60+ countries since 2003
Management systems and compliance programmes delivered across regions, with one engagement team accountable wherever your design and manufacturing sites are.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with third-party costs shown separately. No surprises, ever.
Built into design, not bolted on
The process follows your design control and your risk file, so engineers see it as part of the job rather than extra paperwork.
Expert and experienced consultants
Consultants with medical device quality and risk management experience across sectors and countries, who build the process properly the first time.
The Sterling Promise
What our IEC 62366-1 success guarantee means
We stay with you until your agreed IEC 62366-1 outcome is achieved, supporting the gap analysis, the process, the evaluations and the completed file for the agreed devices. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the standard, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed process into use. IEC 62366-1 has no certificate; regulators, notified bodies and auditors reach their own decisions on your devices and files. Our commitment concerns the agreed support, not a promise that no use error will ever occur.
FAQs
Frequently asked questions about IEC 62366-1
Can a company be certified to IEC 62366-1?
No. IEC 62366-1 defines a process a manufacturer applies to each device; there is no certificate for a company to hold. Conformity is shown in the usability engineering file, which auditors and reviewers read as part of the work they already do. Sterling does not issue any IEC 62366-1 certificate.
What is the difference between IEC 62366-1 and IEC 62366-2?
Part 1 contains the requirements; Part 2 is a technical report of guidance. IEC TR 62366-2:2016 explains how to apply the Part 1 process and describes methods that also serve goals beyond safety, but it sets no requirements of its own. It is currently being revised.
Does IEC 62366-1 cover deliberate misuse of a device?
Only partly. The process can identify abnormal use, but it does not assess or mitigate the risks of that use. Its assessment and risk reduction apply to normal use, meaning correct use and use errors.
Which ISO 14971 edition should the usability work link to?
Link it to the risk management process you run today, which should follow ISO 14971:2019, the current edition. The 2015 text of IEC 62366-1 was written to strengthen its links with ISO 14971:2007; work from consolidated edition 1.1 so that you read the text as amended in 2020.
Is IEC 62366-1 mandatory for medical devices?
Not in itself: it is a voluntary international standard. What regulators do expect is evidence that use-related risks were identified and controlled, and whether a given market recognises IEC 62366-1 as a way to show it has to be confirmed market by market. We check this at the start of the gap analysis, alongside your regulatory advisers.
Keep exploring
More on IEC 62366-1 and related standards
More in Healthcare, medical devices & life sciences
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