EN IEC 62366 Medical Device Usability Course

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Use errors caused by inadequate medical device usability have become a growing concern for regulators, manufacturers and healthcare providers. It is the responsibility of medical device manufacturers to reduce all risk as far as possible, including usability-related risks. This highly interactive one-day training course provides a clear pathway to understanding and applying EN IEC 62366, together with guidance from the MHRA and US FDA, enabling learners to achieve compliance and apply the standard effectively to minimise usability-related risks. The course guides attendees thought the establishment of a Usability Process, how to achieve compliance with EN IEC 62366 and how to use the standard to minimise usability-related risks. The course involves interactive group exercises throughout.

We can tailor the training to meet your specific training needs and incorporate examples from your processes and procedures into the training programme as required.

This course provides a detailed exploration of EN IEC 62366 requirements and their practical application. The training examines the usability engineering process and how it supports compliance and safety.

Topics include:

MDR regulatory framework for Usability Engineering
Relationship between EN IEC 62366, EN ISO 14971, and EN IEC 60601-1-6
Usability Engineering Process overview
Documentation requirements for new and legacy products
Development of Use Specifications
Task Analysis
Risk assessment - identification of potential use errors, hazards, and hazardous situations
Formative and summative evaluation processes and reporting
Addressing User Interfaces of Unknown Provenance (UOUP)
Integration of MHRA and FDA usability guidance with EN IEC 62366

The training involves practical exercises, with learners encouraged to apply principles to examples from their own workplace. If required, content may be tailored to reflect your organisation’s specific processes, risk profile, and regulatory setting.

This course is designed for professionals in the medical device industry who require a solid grounding in Usability and Human Factors Engineering. The training is particularly beneficial for those involved in:

Engineering and product development
Quality assurance and regulatory compliance
Risk management
Medical device software and hardware design and development

A good standard of written and spoken English is important to engage effectively with this programme.

On successful completion of this course, learners will be able to:

Identify the EU and US regulations relating to Usability Engineering and Human Factors assessment.
Explain the steps involved in establishing and maintaining a Usability Engineering process.
Prepare and evaluate the required documentation for usability compliance in both new and legacy products.
Develop and apply effective Use Specifications and hazard-related use scenarios.
Conduct formative and summative evaluations and prepare the associated reports.
Utilise EN IEC 62366 in conjunction with EN ISO 14971 and EN IEC 60601-1-6.
Implement requirements for User Interfaces of Unknown Provenance (UOUP).

These outcomes ensure that learners return with the practical skills and knowledge necessary to usability engineering projects and prepare the required usability-related documentation and reports.

This course is delivered by industry experts with deep knowledge of usability engineering and medical device regulation. Each Tutor brings a wealth of industry experience, sector-specific insights, and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support.

Learners benefit from the tutors’ guidance and practical insight, ensuring real application of the training to workplace challenges.

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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To consolidate learning and reinforce key concepts, learners complete a post-course assessment. The assessment:

Checks understanding of course content and practical scenarios
Evaluates applied knowledge of usability and risk principles
Is completed within one week of course completion

Successful learners receive a Certificate of Achievement in addition to their Certificate of Attendance.

Our training approach is practical, highly interactive, and discussion-based, with flexibility to meet organisational needs

Pre-training consultation for in-company courses to tailor content to organisational needs
Emphasis on industry specific application through practical exercises, case studies, and group activities that reinforce key concepts and encourage active participation.
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Live training is available virtually or delivered onsite to suit the needs of the team
Real-time support from expert tutors

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support.

Learners who complete this course often continue to deepen their skills in:

Medical Device Risk Management and ISO 14971:2019
Validation of Software as a Medical Device and EN IEC 62304
Software Validation (for Production and QMS applications)
21 CFR Part 11 Electronic Records and Electronic Signatures and Data Integrity
ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)
Technical Writing Skills

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Course Code

LS040

Duration

1 training day

Delivery Mode

This programme is delivered by or In-Company training

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