LinkedIn Live
MedTech regulatory teams used to ask if AI had a place in their workflows. Now, teams are using it, but they’re not sure if they’re using it responsibly, efficiently, and in a way that stands up to regulatory scrutiny.
In this LinkedIn Live, RQM+’s Jai Kutty, VP, Cardiovascular Center of Excellence, leads an expert panel through the practical realities of AI adoption in MedTech regulatory affairs, offering essential insights on everything from day-to-day use cases and validation frameworks to QMS governance and what notified bodies expect to see.
What’s Covered
- How regulatory teams are using AI today: Real use cases in regulatory intelligence monitoring, literature review for CERs, and QMS documentation drafting
- AI risk boundaries: How to assess AI tool risk based on agency, probability of error, and severity of harm
- What notified bodies expect: The minimum QMS requirements for AI use, including vendor management, change control, and competency training records
- When AI adds complexity instead of efficiency: The AI mistakes that can derail regulatory strategies, including hallucinated predicates and over-reliance on automated outputs
- Proven validation frameworks: How to validate AI tools proportionally, manage model versioning, and know when human oversight is nonnegotiable
- Privacy and PII safeguards: Practical approaches to protecting patient data when using LLMs
- The EU AI Act: What deployer responsibilities mean for MedTech manufacturers using AI in regulated processes
Who This Is For
Regulatory affairs professionals, QA/RA leaders, and clinical teams at medical device and IVD companies who are actively exploring or expanding AI use in their regulatory workflows and want a framework for doing it defensibly.
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