Live Session - How it works
- Username and Password will be emailed to you within 24 hours prior to the date of the webinar.
- Presentation handouts in pdf format will be emailed to you along with the login instructions.
- Login to the session by clicking on “Join the Meeting” in the instructions provided by email and then dial the number to connect to the meeting audio or use your Computer to connect to audio (Connect to the audio using your phone - Recommended). Please use the exact name and the email address you used at the time of registration to join the meeting.
- Get answers to your questions through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions. You can also type in your questions using Chat box in the meeting window.
- Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve our Training programs.
- Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you haven't received an email within 6 working days. Please email our firstname.lastname@example.org
Recorded Session - How it works
- Login Information with Password to access the webinar recording will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is valid for 6 months.
- Please click on the link to access the Recording and type in the password provided in the email.
- Presentation and other handouts will be emailed to you in a pdf format.
Training CD/ USB - How it works
The order will be processed within 2 working days from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at email@example.com.
This webinar will explain the procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Why should must attend:
Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post test participant inquiry is critical to validation success. we will describe how to do this. handouts are usability validation tracking form,protocol form, and test results report form
Areas Covered in the Session:
- Required number of participants
- Qualitative success criteria
- Choice of tasks to validate
- Post test participant inquiry
Who will benefit:
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Engineering management
- Medical Device Industries
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.