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on-demand webinar

The Future of Change Management for Cloud-based AI/ML Medical Software

Recorded on 

Join us for an online webinar on how to implement AI/ML best practices for change management. This event is designed to bring developers and quality/regulatory professionals the latest insights into FDA requirements for AI/ML in medical software, and how to execute reliable and safe change management with fast release cycles.

What you'll learn

The rapid adoption of AI/ML in cloud-based medical software demands effective change management. This session explores the challenges posed by AI/ML in software and provides a framework to validate AI/ML-based applications, ensure FDA compliance, and prevent product development delays. 

Learning Objectives:

1. Understanding AI/ML validation challenges: Understand the challenges and opportunities in AI/ML validation and refine your team’s SOPs.

2. Get the latest on FDA Requirements: Learn about FDA expectations and relevant guidances to AI/ML in medical software including the April 2023 draft guidance, Marketing Submission Recommendations for a Predetermine Change Control Plan for AI/ML-enabled device Software Functions.

3. Effective change management strategies for RA teams: Learn best practices tailored for software development teams confronting the reality of incorporating AI/ML into medical device software. The focus will be on strategies that ensure FDA compliance and enable rapid, responsive, and reliable change management.

Who should attend

  • Research and development teams
  • Regulatory affairs and compliance personnel
  • Software development teams
  • Professionals working in medical device software

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Erez Kaminski

Founder & CEO


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