IEC 62366-1 · FDA HUMAN FACTORS GUIDANCE · EU MDR ANNEX I
IEC 62366-1: Usability Engineering of Medical Devices
Most usability engineering files fail late and for the same reason. The evaluation itself is well run: fifteen participants per group, a realistic environment, a facilitator who does not interfere. What it evaluates is a set of scenarios that was already incomplete three steps earlier. This course follows the process one clause at a time, so you can read a file and say what is missing from it.
Scope
What the course covers
Where a requirement is quoted, it is quoted in full and then explained. Where something is an interpretation rather than a rule, the course says so.
01
The process, step by step
Clause 5 in ten steps, from the use specification to the summative evaluation, plus the general requirements of clause 4 that apply throughout. Every module opens with the requirement, quoted by clause number, and states what compliance to it consists of.
02
The documents the process produces
What a use specification, a hazard-related use scenario, a user interface specification, an evaluation plan and a summative report actually contain, and how each is structured so the next step can use it.
03
Hazards that arise without a failure
The category this standard exists for: a hazardous situation reached while every component performs exactly as specified, which a failure analysis cannot find.
04
Selection, and what it commits you to
The two options the standard allows, the three records the file has to carry, and how the number of scenarios and user groups sets the size of the evaluation.
05
The United States layer
Critical tasks, the fifteen-participant minimum per distinct user population, the rules on instructions and training during validation, and the treatment of residual risk in a submission.
06
Legacy interfaces
The alternative route for an interface inherited from an earlier product: what qualifies, what a modification does to the classification, and what the route does not require.
Outline
13 modules, in the order the process runs
The course follows the sequence of the work rather than the numbering of the regulation, and ends where the work ends.
Introduction
What the standard is for, and how the course is arrangedScope, applicability and the vocabulary of use
Normal use, correct use, abnormal usePrinciples and the usability engineering file
Clause 4, risk control priority, tailoringUse specification
The six elements clause 5.1 requiresUser interface characteristics and use errors
Task analysis, and where an error startsKnown and foreseeable hazards and hazardous situations
Three named inputs, and abnormal useHazard-related use scenarios
Tasks, sequence, severitySelecting the scenarios for summative evaluation
Two options, three records, critical tasksThe user interface specification
Testable requirements, and two indicationsThe evaluation plan
Formative and summative, per scenarioDesign, implementation and formative evaluation
The loop back into clause 5Summative evaluation
Analysis, root causes, residual riskUnknown provenance, and the file
The alternative route, and what closes the fileFinal test
Covering the whole courseOutcomes
What you will be able to do
01
Read a usability engineering file
And say which of the ten steps is missing, thin, or written against a version of the use specification that no longer exists.
02
Produce the documents the standard requires
A use specification with its six elements, scenarios described task by task, requirements for which a pass condition can be written.
03
Defend the selection
State the scheme, the reason it suits this device, and what it produced — including the scenarios it excluded.
04
Plan an evaluation that can be used as evidence
With the participants, conditions, documentation and training decided before recruitment rather than during it.
05
Work both routes
Convert selected scenarios into the critical tasks a United States submission expects, and know why the reverse does not work.
Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every module replayable. Transcripts are downloadable, so the content stays searchable long after the video is finished. Access does not expire, and revisions made after your purchase are included.
Audience
Who the course is for
- Regulatory affairs managers assembling technical documentation for a device with a user interface
- Quality managers who review a usability engineering file before it leaves the building
- PRRCs and persons responsible for regulatory compliance at device manufacturers
- Consultants who audit or remediate usability files
- Project managers deciding when formative evaluation has to happen for it to still matter
It assumes familiarity with medical device regulation and with a quality management system. It does not assume prior study of the articles and annexes it covers.
Certificate
Verifiable by a third party
On passing the final test, the certificate carries a verification code derived from your name and the date of completion.
An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under your quality system.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you enrol
Do I need a copy of IEC 62366-1 to follow the course?
No. Every requirement is quoted by clause number and explained in the module that covers it. You will want the standard when you come to write your own file, because the file has to cite it, but the course does not depend on you having it open.
How much does this overlap with a risk management course?
Very little, deliberately. Hazard, hazardous situation, severity and residual risk are defined in ISO 14971 and assumed here. What this course adds is the one thing usability has a standard of its own for: a hazardous situation can arise while every component performs exactly as specified.
Does it cover the FDA route as well as the European one?
Yes, as a parallel layer rather than a separate section. The guidance appears wherever it states something the standard does not: critical tasks, the fifteen-participant minimum, the rules on instructions and training during validation, and residual risk in a submission.
Which edition is the course written against?
The 2015 edition, with the clause numbering the 2020 amendment leaves unchanged. Module 01 covers how to check which edition your own file works from, and which applies on your regulatory route — two different questions.
Is it for engineers or for regulatory staff?
For the people who govern the process and read the file. It assumes you work with risk management; it does not assume you design user interfaces.
How long do I have access?
Access does not expire. The course stays in your account, including any updates made to the modules after your purchase.
Is there a certificate?
Yes. Passing the final test issues a certificate with a verification code, which anyone can check on our verification page.
Can I watch the modules in any order?
The modules unlock in sequence, because each one builds on the previous. Once unlocked, a module stays available and can be rewatched.
Do I need any prior knowledge?
The course assumes you work in the sector and know what a technical file and a notified body are. No knowledge of the specific technology is assumed.
Can my company buy several seats?
Yes. Write to us and we will set up team access with a single invoice.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook included with the course is a gap analysis of your own documentation, arranged in the order an assessment runs. Working through it produces a list of what is missing or partial in your file.
That list maps to the templates in the MDR Technical File Kit.
Enrol
The usability engineering process, one clause at a time, with the documents it has to produce.
13 modules, 2 hours 32 minutes of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.