Event Details
16 hours (2 days x 8 hours per day)
Available virtually
This course includes extensive hands-on study of the IEC 62366-1:2015+A1:2020 standard using application examples to reinforce learning.
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Please contact us if you are interested in private training for this workshop.
16 hours (2 days x 8 hours per day)
Available virtually
IEC 62366-1:2015+A1:2020 specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. This course provides a detailed presentation across 12 topics listed below and includes key check points and questions to ask as the design progresses towards the design transfer stage. A 60 Question Quiz to help practice and reinforce key concepts covered in the session.
This course includes extensive hands-on study of the standard using application examples to reinforce learning. Depending on the duration a complete case study may be used to enable participants to get firsthand experience of how to apply and meet the requirements of the standard. Time permitting some customization, and application to participant’s products may also be discussed.
This course is most suitable for Managers and Leaders and all those work with Product development/managing product teams.
Through training, Design and Development staff, Quality/Regulatory professionals, New/Sustaining Product Engineers, and others will learn to apply/practice usability principles in their work setting.
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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