Who it’s for
Who should attend
Human factors and design engineers, industrial designers, systems engineers, risk managers, regulatory and quality staff, and the clinical or marketing personnel who define intended users and use environments.
Curriculum
Course modules
- Why usability is a regulatory requirement; use error as a source of harm
- Relationship between IEC 62366-1, IEC 60601-1-6 and ISO 14971
- Terminology: use error, abnormal use, use scenario, user interface, primary operating function
- Preparing the use specification
- Identifying user interface characteristics related to safety and known or foreseeable hazards
- Identifying and describing hazard-related use scenarios
- Selecting hazard-related use scenarios for summative evaluation
- Establishing the user interface specification
- The user interface evaluation plan
- Formative evaluation during design
- Summative evaluation: design, participants, moderation and analysis
- The usability engineering file
- User interface of unknown provenance
- Post-market usability feedback
- Alignment with FDA human factors expectations
Outcomes
What you’ll be able to do
- Run the usability engineering process end to end
- Design and defend a summative evaluation
- Assemble a usability engineering file that withstands review
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Usability for Medical Devices”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.