Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Who Will Benefit

This online training has been developed and is intended for professionals in the Medical Device and diagnostic industries. It will be especially beneficial to personnel working in the following areas and positions:

  • Software Engineers
  • Engineers
  • Quality Assurance
  • Regulatory
  • Marketing
  • Management


What Can and Cannot Be Done

Artificial Intelligence/ Machine Learning (AI/ML) will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidances for years, however, AI/ML programs fall outside the scope of these regulations and guidances. This happens because FDA approves the final, validated version of the software. The point of AI/ML is to learn and update following deployment to improve performance. Thus the field version of the software is no longer the validated approved version.

This 60-minute accredited online training will address the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Development personnel should understand these concepts because, with some modifications, they will probably become regulations. It is currently not clear how to get AI/ML programs approved by FDA. Following discussion of possible future regulation, we will discuss, based on recently approved De Novo applications, how to get your AI/ML program approved now.

Necessary submission documentation will be explained.

This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML. Attendees will receive a multi-page outline and checklist.

Faculty Edwin Waldbusser

Edwin Waldbusser

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 12 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.

Choose a Pricing Option


Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 location. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


MP3 Download - Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.