Overview

Navigate Course Details

Course Overview

  • Duration: 8 hours
  • Cost: $950 USD

This course provides a robust introduction to human factors and usability engineering in medical devices. Participants will explore how user interactions impact safety and effectiveness of medical devices (MDs).

Through in-depth discussions on ISO 62366-1: 2015, ISO 14971:2019, IEC 60601-1-6:2010, and other relevant standards, participants will learn to:

  • Identify use-related risks and hazard-related use scenarios
  • Implement usability risk assessment strategies
  • Conduct formative and summative usability testing

By applying these principles, participants will develop practical skills to assess and enhance device user interfaces. The course will also emphasize user-centered design and strategies to minimize use-related hazards, including cybersecurity and software usability considerations.

Learning Objectives
This course will equip participants with a greater understanding of the following areas:

  • Usability engineering process
  • Identification of user interface characteristics in relation to safety
  • Usability risk assessment
  • Hazard-related use scenarios
  • Formative usability testing
  • Summative usability testing
  • Usability engineering file (UEF)
  • Usability and human factors compliance determination
  • Relevance of other applicable standards

Ideal Target Audience
This course is designed for professionals involved in development, regulation and compliance of MDs and in vitro diagnostic devices (IVDs), including regulatory affairs and quality assurance (RAQA) specialists and product managers. It is particularly beneficial for individuals looking to deepen their knowledge of ISO 62366, the Medical Device Regulation (MDR), and the In Vitro Diagnostic Regulation (IVDR) to validate compliance with the usability engineering requirements.

Instructor Information
Our trainers have extensive expertise in certification processes and have worked with world-class manufacturers.

Dr. Subramanian Murugan has over a decade of experience in regulatory affairs and quality assurance, specializing in usability engineering and human factors for MDs and IVDs. He has successfully guided numerous regulatory submissions, helping manufactures demonstrate compliance with applicable global regulations. His expertise includes:

  • Implementing the usability engineering process (ISO 62366-1:2015+Amd 2020)
  • Integrating human factors engineering into risk management (ISO14971:2019)
  • Aligning medical software usability with MDSW Life Cycle Processes (IEC 62304)
  • Verifying compliance with IEC 60601-1-6 for medical electrical equipment usability

With more than 15 years of international experience within the IVD industry, Naomi Knopjes has expertise in manufacturing, design, and development, with a strong focus on compliance validation and verification of IVDs. She has worked extensively in:

  • Design and risk-management for IVDs
  • Formative and summative evaluations for IVDs, helping validate that these devices are safe, effective, and useable.
  • Usability engineering (ISO 62366-1:2015)
  • Management of usability related risks (ISO14971:2019).

Benefits of our Training

  • Gain Confidence: You can learn to systematically identify and mitigate use-related risks and design implementation to prevent misuse and ensure patient safety. Training on relevant standards will allow you to address necessary regulatory requirements and help you navigate the intricacies of EU regulatory systems.
  • Expert Instructors: Our experienced trainers bring real-world knowledge and industry-leading insights to the classroom. They have a deep understanding of testing and certification at CSA Group and work with world-class manufacturers.
  • Private or Public: We offer both public and private courses. For organizations with 10 or more participants, we can administer private training courses — allowing your team to ask questions and receive guidance tailored to your business. For organizations with less than 10 participants, we recommend our public courses. Our public courses have been designed by our industry experts to help your team understand a range of complex topics.
  • Hands-On Learning: Engage in practical exercises, case studies, and simulations to reinforce your understanding.
  • Certificate: Earn a Certificate of Completion upon successful completion of each course.

Go to the Top