Usability — Integrating ergonomics and usability engineering from the design stage (IEC 62366)
Designing a medical device also means designing the interaction between that device and its real users. EN IEC 62366-1 requires manufacturers to structure this approach from the earliest stages of development: defining the user profile, task analysis, identifying foreseeable errors, formative and summative evaluations. Too often relegated to a documentary step at the end of a project, usability engineering is in fact an engineering process in its own right, directly articulated with ISO 14971 risk management and the essential requirements of the MDR Regulation 2017/745.
Audience R&D engineers, product/interface designers, regulatory affairs (RA) managers, design project managers, anyone involved in the development of a medical device subject to CE regulation.
Learning objectives
- ▸ Position the requirements of EN IEC 62366-1 within the MDR 2017/745 regulatory framework (Annex I, GSPR No. 5) and identify their links with ISO 14971 and IEC 62304
- ▸ Define the profile of intended users, the use environments and the critical tasks associated with their device
- ▸ Build a usability engineering process plan (Usability Engineering File) compliant with the requirements of the standard
- ▸ Distinguish formative evaluation from summative evaluation, and plan the corresponding activities during design
- ▸ Identify foreseeable use errors and reasonably foreseeable misuse, and integrate them into the risk analysis
- ▸ Prepare the key documents expected by a notified body in the technical documentation: usability plan, summative evaluation report
Expected outcomes
- ✓ Launch or audit the usability engineering process of their organization
- ✓ Produce the associated documentary deliverables (usability plan, summative evaluation report)
- ✓ Anticipate the control points examined during a technical documentation or certification audit
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Basic knowledge of the MDR 2017/745 regulatory framework recommended. Experience in a medical device design or development environment is an asset. No formal blocking prerequisites.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi certified and is not eligible for funding via the OPCO
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory and normative framework (1 h)
- ·Essential requirements of MDR 2017/745 related to usability (Annex I, GSPR No. 5)
- ·Overview of applicable standards: EN IEC 62366-1, EN IEC 62366-2, EN IEC 60601-1-6
- ·Articulation with risk management (ISO 14971) and software development (IEC 62304)
- ·Expectations of notified bodies during the examination of the technical documentation
- 02
Fundamentals of usability engineering (1 h 30)
- ·Key definitions: intended users, use environments, user interface, normal use, use error, reasonably foreseeable misuse
- ·Relationship between safety ergonomics and comfort ergonomics
- ·Main causes of incidents related to usability: field feedback
- 03
Structuring the usability engineering process (2 h — workshop)
- ·Development of the usability engineering process plan
- ·Definition of the user profile and user groups
- ·Analysis of critical user tasks
- ·Identification of use scenarios and foreseeable errors
- ·Integration into the product development plan: milestones, deliverables, responsibilities
- 04
Formative and summative evaluations (1 h 30)
- ·Distinction between formative evaluation (iterative, during design) and summative evaluation (final validation before market launch)
- ·Evaluation methods: user testing, interviews, use simulations
- ·Acceptability threshold and success criteria
- ·Preparation of the protocol and the summative evaluation report
- 05
Usability file and link with the MDR technical documentation (1 h — exercise)
- ·Expected content of the Usability Engineering File
- ·Traceability between usability deliverables and the sections of the MDR technical documentation
- ·Points of attention during a certification or surveillance audit
Assessment of learning
Assessment methods
QCM validation at the end of the day (20 questions covering modules 1 to 5) and a case-study exercise applied to module 5. A self-assessment grid of competencies is provided at the beginning and end of the training to measure individual progress.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in all modules. This certificate does not constitute a certification recognized under the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
890 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi certified and is not eligible for funding via the OPCO
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.