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Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Availabile as a virtual, instructor-led class.

Usability / human factors analysis is becoming an area of focus within standards and global regulations. It is important to understand how your users may interact with your device in order to ensure that the device functions properly and all potential safety issues are understood. Human factors studies are part of the design process and should be integrated into device risk analysis. This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process.

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

 
There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

What You Will Learn

 
At the end of this workshop, you will be able to:
  • Describe the usability requirements in quality management system standards and regulations (IEC 62366-1:2020, ISO 13485:2016, ISO 14971:2019, EU IVDR Annex I, FDA)
  • Provide an analysis of the requirements of the IEC 62366-1:2020
  • Illustrate the interactions between risk management and usability engineering
  • Practice documenting potential failure modes in usability and their effects
  • Describe the links between design usability, risk management, and complaints
  • Establish examples of traceability among user-related hazards, risk mitigations, product requirements, and verification / validation results
  • Determine procedures and evidence needed to demonstrate compliance to usability requirements in IEC 62366-1:2020 and related standards / regulations
  • Evaluate best practices in usability elements of premarket submissions

Who Should Attend

 
Anyone from the medical device and in vitro diagnostic device industry involved in development, including regulatory personnel. Recommended for staff with the specific responsibility of risk management, as well as quality engineering, technical services, operations, QA/QC, regulatory, and research and development.

Course Days

Virtual Class Days: 5 days, Monday - Friday daily 1:00 - 5:00 p.m.

Classes run either on Eastern Time or Central European Time as indicated in the virtual class "Location" field

Virtual Half-Days: 5
In-Person Full-Days: 3
CEUs: 2.4

Virtual Session Details

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.  Each VILT session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

  • This class is delivered across 5 consecutive half-days (Monday to Friday) 1 p.m.-5 p.m.
    • Classes run either on Eastern time or Central European time as indicated in the virtual class "Location" field
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical / Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

 

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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