IEC 62366-1: Usability Engineering of Medical Devices
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
IEC 62366-1 · FDA HUMAN FACTORS GUIDANCE · EU MDR ANNEX I
IEC 62366-1: Usability Engineering of Medical Devices
Thirteen modules that follow the usability engineering process one clause at a time, so you can read a usability engineering file and say what is missing from it.
€229
VAT calculated at checkout
13 modules · 2h 32 of video · Certificate
Access does not expire
The summative evaluation is run correctly, against the wrong set of scenarios
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, because the use specification named one average user instead of four profiles, or because the hazard identification recorded hazards and not the situations in which someone is exposed to them.
The standard is unusual in that every one of its clauses is checked the same way: by inspection of the usability engineering file. Nothing is checked by asking how the work was done. That makes the file the deliverable, and it makes the gaps in it cheap to find and expensive to have missed.
None of this is difficult. It is the consequence of reading IEC 62366-1 as a list of clauses rather than as a chain of documents, each of which is named as an input by the one after it.
- 13 modules
- 2h 32 of video
- Self-paced
- Workbook included
- Certificate on completion
- Access does not expire
Scope
What the course covers
The course is built on clause 5 of the standard, one module per step, in the order the standard sets them out. United States practice is carried alongside it wherever the guidance states something the standard does not, rather than as a separate track.
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 one is structured so the next step can use it.
03
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.
Outline
13 modules, in the order the standard is built
Audience
Who the course is for
- Regulatory affairs managers assembling technical documentation for a device with a user interface
- Quality managers who have to review a usability engineering file before it leaves the building
- PRRC 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
The course assumes you work with risk management and know what a hazardous situation and a residual risk are. It does not assume you design user interfaces: it is written for the people who govern the process and read the file, not for the people who draw the screens.
What is included
What you get when you buy
- 13 video modules, 2h 32 of video, self-paced
- A short quiz after every module, five questions each
- A final test covering the whole course
- A 19-section workbook that runs a gap analysis on your own usability engineering file
- An exercise in every module producing one number from your own documentation
- Certificate on completion, with a verification code
- Access that does not expire
The certificate
Issued on passing the final test. It records the course, the date and the holder, and carries a code that anyone can check against the register — an employer, an auditor, or a client asking what your team has been trained on.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
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 itself when you come to write or revise your own file, because the file has to cite it, but the course does not depend on you having it open.
Which edition is the course written against?
The 2015 edition, with the clause numbering that the 2020 amendment leaves unchanged. Module 01 covers explicitly how to check which edition your own file works from, and which one applies on your regulatory route, since those are two different questions.
Is usability engineering mandatory?
Applying a usability engineering process is how manufacturers demonstrate that the requirements on use error in Annex I of the regulation have been met. In the United States, the guidance applies where the risk analysis indicates that use errors could cause serious harm. Neither framework makes the standard itself compulsory; both make the outcome it produces necessary.
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 are 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 of the device 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 per distinct user population, the rules on instructions and training during validation, and how residual risk is treated in a submission.
Is it live or self-paced?
Self-paced. The modules run ten to fifteen minutes each and are watched in any order, though the process they describe only makes sense in sequence, because each step names the previous ones as its inputs.
What does the workbook do?
It runs a gap analysis on your own file. Nineteen sections ordered by dependency rather than by clause number, with three sections that apply only in specific cases: device-specific training, the United States market, and interfaces inherited from an earlier product. One section asks only for dates, which is usually the section that shows whether the file is maintained.
Can I watch part of it before buying?
Module 00 is free. It covers what the standard is for, how the twelve content modules are arranged, and what the course deliberately leaves out. About ten minutes.
What happens if I fail the final test?
You retake it. There is no limit and no waiting period, and the questions cover the same ground as the module quizzes, so the modules where you lost marks are the ones to rewatch first.
Can I buy several seats for a team?
Yes. Contact us before purchasing and we will set the seats up under one invoice, with the certificates issued individually.
IEC 62366-1: Usability Engineering of Medical Devices
Thirteen modules, 2h 32 of video, and a workbook that runs a gap analysis on your own usability engineering file. Self-paced, certificate on completion, access does not expire.
€229.00
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