This course includes extensive hands-on study of the IEC 62366-1:2015+A1:2020 standard using application examples to reinforce learning.
$1,777.00
Contact us to get notifications about future courses or to schedule a private workshop.
16 hours (2 days x 8 hours per day)
Available virtually
Start date: September 18, 2024
End date: September 19, 2024
Start time: 08:30 a.m. EDT
End time: 04:30 p.m. EDT
Venue: Virtual on Zoom
Directions: Training will occur on Zoom. You will be provided with a unique link per registrant. Please plan to login 10 minutes prior to the session start time.
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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