Faculty: José Mora


  • Date: 10/18/2022 11:00 AM - 10/18/2022 12:00 PM
  • Location: Online Event

Tickets


Ticket Type
Qty
Live- Single
$200.00
0
For ONE Participant – Live session only
Live Corporate
$700.00
0
For Maximum of 10 participants – Live session only
Recording - Single
$350.00
0
Recording - Corporate
$1400.00
0

Total

$0.00

Description

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 guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus the field version of the software is no longer the validated approved version.

We will discuss the current regulatory requirements, how they don’t control AI/ML adequately, and approaches FDA is considering for regulation in the near future. Your development program should conform to these concepts now because, with some modifications, they will probably become regulations. Following a discussion of possible future regulations, 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

Why You Should Attend:

It is not clear how to get AI/ML programs approved. The current regulatory requirements don’t control AI/ML adequately. We will discuss the approaches FDA is considering for regulation in the near future and how to get your AI/ML program approved by the FDA now. Necessary submission documentation will be explained. Attendees will receive a multipage outline and checklist.

Areas Covered in the Session :

  • Required number of participants
  • Qualitative success criteria
  • Choice of tasks to validate
  • Post-test participant inquiry. Forms: Usability Validation Tracking Matrix
  • Validation Protocol
  • Validation Test Results Report will be given as Handouts

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Engineering Departments
  • Software Engineers
  • Marketing Departments
  • IT Departments
  • Management Teams