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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
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 dont 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.
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
Edwin Waldbusser
Regulatory Consultant