IEC 62366-1: Usability Engineering of Medical Devices
Maximum Added Value: Usability Engineering in the Development Process of Medical Devices
Usability is a critical safety and performance characteristic of medical devices. IEC 62366-1 establishes a structured usability engineering process that helps manufacturers identify, evaluate, and mitigate risks associated with use errors while improving device safety and user performance.
This practical training provides an in-depth understanding of IEC 62366-1:2015+A1:2020 and its relationship with MDR, IVDR, FDA Human Factors guidance, and ISO 14971 risk management. Through real-world examples and interactive exercises, participants learn how to implement usability engineering efficiently throughout the development lifecycle of medical devices.
At the end of this training, you will:
- Learn how to systematically develop medical devices that are fit for use and safe to use.
- Know how to avoid user errors through clever design of medical devices.
- Receive concrete information on the efficient implementation of the normative requirements for the usability of medical devices.
Course testimonial:
- "The practical examples and real-world implementation experience shared by the instructor made the regulatory requirements easy to understand and apply. The interaction with an industry expert provided valuable insights beyond the standard itself."
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is intended for:
- Usability Engineers
- Human Factors Engineers
- User Experience (UX) Professionals
- Product Development Engineers
- Design Engineers
- System Engineers
- Software Engineers involved in medical devices
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- Risk Management Specialists
- Product Managers
- Design Verification and Validation Engineers
- Medical Device Project Managers
- Clinical Affairs Professionals
Module 1: Introduction to Usability Engineering
- Usability fundamentals
- Human factors and patient safety
- Regulatory drivers for usability engineering
- Use errors and their impact on medical device safety
Module 2: Regulatory Requirements and Standards
- MDR and IVDR usability requirements
- IEC 62366-1:2015+A1:2020 overview
- IEC/TR 62366-2 guidance
- FDA Human Factors Engineering guidance
- Related standards and best practices
Module 3: Usability Engineering Process According to IEC 62366-1
- Use specification development
- User profiles and personas
- Use environments
- User interface characteristics related to safety
- Hazard identification
- Hazard-related use scenarios
- Relationship between usability engineering and ISO 14971
- User interface specification development
- Usability engineering documentation and file structure
Module 4: User Interface Evaluation
- Formative evaluations
- Summative evaluations
- Planning usability tests
- Use errors, use difficulties, and close calls
- Test protocols and reporting
- Validation evidence
Module 5: Additional Considerations
- Legacy products and UOUP (User Interface of Unknown Provenance)
- Post-market usability considerations
- FDA-specific expectations
- Practical implementation strategies
Practical Workshops
- Creating a use specification
- Developing hazard-related use scenarios
- Identifying use errors
- Planning usability testing activities
Medical device failures are often caused not only by technical malfunctions but also by usability deficiencies that can lead to user errors and hazardous situations. Regulatory authorities worldwide increasingly expect manufacturers to demonstrate that usability engineering has been systematically integrated into device development.
This training provides a practical understanding of the requirements of IEC 62366-1:2015+A1:2020 and explains how usability engineering supports compliance with EU MDR, IVDR, and international regulatory expectations. Participants will learn how usability contributes to device safety, performance, and successful market access.
The course walks participants through the complete usability engineering process, including creation of the use specification, identification of user-interface-related hazards and use errors, development of hazard-related use scenarios, establishment of user interface requirements, and creation of usability engineering documentation.
Special attention is given to integrating usability engineering activities with ISO 14971 risk management processes. Participants will learn how to evaluate use-related risks, develop risk control measures, and generate objective evidence that a device can be used safely and effectively by intended users.
Through practical exercises, case studies, and workshop activities, attendees gain hands-on experience in applying usability engineering methods, planning formative and summative evaluations, and preparing documentation that supports regulatory submissions and design validation activities.
By the end of this course, participants will be able to:
- Explain the purpose and scope of IEC 62366-1.
- Interpret usability-related requirements of MDR and IVDR.
- Define key usability engineering terminology and concepts.
- Develop a compliant usability engineering process.
- Create use specifications, user profiles, and use environment descriptions.
- Identify user-interface-related hazards and potential use errors.
- Develop hazard-related use scenarios.
- Establish user interface requirements and specifications.
- Integrate usability engineering activities within ISO 14971 risk management.
- Plan formative and summative usability evaluations.
- Document usability activities and maintain a usability engineering file.
- Apply practical usability engineering techniques throughout the product lifecycle.
Upon completion of this course, you will be able to:
- Understand the requirements of IEC 62366-1:2015+A1:2020.
- Implement an effective usability engineering process for medical devices.
- Integrate usability engineering activities with ISO 14971 risk management.
- Address MDR and IVDR usability-related requirements.
- Identify and evaluate use errors and hazard-related use scenarios.
- Develop user profiles, use specifications, and user interface requirements.
- Plan and conduct formative and summative usability evaluations.
- Understand FDA expectations related to human factors engineering.
- Improve product safety while enhancing user experience.
- Create documentation suitable for audits, technical files, and regulatory submissions.
This instructor-led live online course combines theory and practical application to maximize learning and retention.
Participants learn through:
- Expert-led presentations
- Interactive discussions
- Real-world medical device examples
- Practical workshops
- Group exercises
- Case studies
- Knowledge-sharing activities
- Q&A sessions with the instructor
The course is delivered in a virtual classroom environment, enabling live interaction, peer discussion, and direct access to subject matter experts. Webcam and microphone participation is recommended to maximize engagement
Participants' understanding will be evaluated through:
- Interactive exercises
- Group workshops
- Case study discussions
- Knowledge checks and instructor-led questioning
- Participation in practical usability engineering activities
Participants who successfully complete the course will receive a Certificate of Attendance from TÜV SÜD Academy.
Participants will receive:
- Digital course presentation materials
- Workshop and exercise materials
- Practical examples and templates used during training
Participants are encouraged to have access to:
- IEC 62366-1:2015+A1:2020
- IEC/TR 62366-2
- ISO 14971
Applicable standards should be purchased through authorized standards distributors. These standards can be purchased through the American National Standards Institute (ANSI) at www.ansi.org, the American Society for Quality (ASQ) at www.asq.org, or any other authorized distributor of international standards.
There are no mandatory prerequisites.
However, familiarity with the following topics is beneficial:
- Medical device development processes
- Medical device regulations
- ISO 14971 risk management principles
- Quality management systems such as ISO 13485
What is IEC 62366-1?
IEC 62366-1 is the international standard that specifies a usability engineering process for medical devices to identify, assess, and reduce use-related risks.
Why is usability engineering important for medical devices?
Poor usability can lead to use errors, hazardous situations, patient harm, and regulatory compliance issues. Usability engineering helps ensure devices are safe and effective for intended users.
Does this course cover MDR and IVDR requirements?
Yes. The course explains how usability engineering supports compliance with MDR and IVDR requirements related to device safety, user interaction, and risk reduction.
How does IEC 62366-1 relate to ISO 14971?
The course explains how usability engineering activities integrate with risk management processes and how use-related risks are addressed within an ISO 14971 framework.
Does the course discuss FDA Human Factors requirements?
Yes. The training includes an overview of relevant FDA guidance documents and discusses key differences and additional expectations for the U.S. market.
Are practical exercises included?
Yes. Participants complete workshop exercises related to use specifications, use errors, hazard-related use scenarios, and usability test planning.
Will I learn how to conduct usability testing?
Yes. The course covers planning, executing, documenting, and evaluating both formative and summative usability evaluations.
Does the course cover software and digital health user interfaces?
Yes. The principles of IEC 62366-1 apply to software-based and hardware-based medical device user interfaces, including connected and digital systems.
Is this course suitable for beginners?
Yes. The course introduces core concepts while also providing sufficient detail for experienced professionals involved in medical device development and compliance.
Will a certificate be issued?
Yes. Participants who attend the course will receive a TÜV SÜD Academy Certificate of Attendance.
Does the training provide implementation guidance?
Yes. The course includes practical methods, examples, workshops, and documentation approaches that participants can apply within their own development processes.
What version of the standard is covered?
The training covers IEC 62366-1:2015+A1:2020 and references associated guidance and related standards.
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