Training Features

Usability Engineering in Compliance with IEC 62366 for Medical Devices

Unlock the key to user safety and device effectiveness by joining our Usability Engineering training on 11 and 18 June 2026, and mastering IEC 62366 compliance for medical devices.
Format

Virtual Training

Level

Basic

Date

11 and 18 June 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Kevin Kenney

Certificate

Certificate included

Price

€ 1195 or equivalent currency

Usability Engineering in Compliance with IEC 62366 for Medical Devices

Usability engineering is a critical aspect of medical device development, ensuring that devices are safe and effective in their actual use and use environment. The IEC 62366 standard provides a structured approach to identifying, assessing, and mitigating risks related to human factors and usability. Compliance with this standard is essential for meeting the requirements of the EU MDR 2017/745, IVDR 2017/746, and FDA human factors guidance. 

Led by Kevin Kenney, this training provides a practical overview of usability engineering in medical device development, focusing on regulatory expectations, risk management, usability testing, and documentation requirements. Participants will gain insights into implementing a usability engineering process that enhances patient safety and regulatory compliance.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Usability engineering is a vital component of medical device development, playing a key role in ensuring that devices are both safe and effective in real-world use. The IEC 62366 standard offers a structured framework for identifying, evaluating, and mitigating risks associated with human factors and usability. Compliance with this standard is not only good practice, it is also essential for meeting the regulatory requirements of the EU MDR 2017/745, IVDR 2017/746, and FDA human factors guidance.

This training delivers a practical and comprehensive overview of usability engineering for medical devices. Participants will explore regulatory expectations, usability risk management, testing strategies, and documentation requirements, while learning how to integrate usability engineering into the design and development process. The training offers actionable insights to help teams build safer devices, improve user experience, and achieve compliance in global markets.
Key Learning Objectives
  • Understand the usability engineering process as defined in IEC 62366
  • Learn how to integrate usability engineering into medical device development
  • Identify and mitigate use-related risks in compliance with ISO 14971
  • Develop effective usability test plans and conduct human factors evaluation
  • Understand regulatory expectations for usability under MDR, IVDR, and FDA
  • Learn how to document usability engineering activities for compliance
  • Gain insights into post-market usability monitoring and continuous improvement
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one sessions, lasting 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 11 and 18 June 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If the June training date is not suitable, additional sessions will be held on 10 and 17 March, 15 and 22 September, and 2 and 9 December 2026. Additional information van be found on the registration pages.
Who Should Attend?
  • Medical device manufacturers and product development teams
  • Regulatory Affairs professionals ensuring compliance with usability requirements
  • Quality Assurance managers integrating usability into QMS processes
  • Human factors engineers and usability specialists in the medical device industry
  • Risk management professionals assessing usability-related risks
  • Clinical and R&D teams involved in device design and user testing
  • Clinical and R&D teams involved in device design and user testing
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework for Usability Engineering
  • Understand the application of IEC 62366-1 usability engineering to medical devices, including its requirements under MDR, IVDR, and FDA guidance, and how to integrate usability engineering into the design and development process.
  • Usability Risk Management and Human Factors Engineering
  • Learn to identify and analyze use-related risks, including foreseeable vs. non-foreseeable use, normal vs. abnormal use, and misuse, in accordance with ISO 14971, and integrate usability risk management to address use errors and improve safety, effectiveness, and evaluation of user interfaces of unknown provenance (UOUP).
  • Usability Engineering Process According to IEC 62366
  • Learn how to plan usability activities, define user needs, conduct formative usability evaluations with iterative design improvements, and perform summative usability testing and validation.
  • Usability Testing and Data Collection
  • Learn how to develop and conduct usability test protocols, recruit representative users, simulate real-use scenarios, and evaluate test results to identify potential design improvements.
  • User Interface (UI) and Design Considerations
  • Understand how to design intuitive user interfaces for medical devices, considering human factors for both hardware and software usability, while addressing accessibility and usability for diverse user groups.
  • Documentation and Compliance Requirements
  • Learn how to prepare usability engineering files for regulatory submissions, align documentation with MDR, IVDR, and FDA requirements, and apply best practices to demonstrate compliance during audits and inspections.
  • Post-Market Considerations for Usability
  • Learn how to monitor usability issues through post-market surveillance, address usability-related complaints and incidents, and implement continuous improvements based on real-world data.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into applying usability engineering in compliance with IEC 62366, ensuring your medical devices meet regulatory expectations under the MDR, IVDR, and FDA guidelines.

Expert-Led IVDR Training for Practical Compliance

Meet the Trainer

Kevin Kenney

Kevin is a consultant at Qserve Group US Inc. with over 15 years of experience in the medical device industry, specializing in electromechanical design, safety compliance, and end-to-end product development from design to manufacturing.