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Using AI in Medical Device Regulatory Affairs
Course Overview
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Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours
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Target Audience: Regulatory and quality professionals implementing AI tools
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Certificate: Professional Development Certificate of Completion
Learning Outcomes
Upon completion, participants will be able to:
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Understand AI applications in regulatory work
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Implement AI tools for literature searches and content creation
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Ensure compliance when using AI in regulated environments
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Develop AI governance frameworks for regulatory teams
Module 1:
AI Fundamentals for Regulatory Professionals
(2 hours)
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AI and machine learning basics
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Current AI tools for regulatory affairs
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Benefits and limitations of AI in compliance work
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Regulatory considerations for AI tool usage
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Homework: AI tool evaluation exercise for specific regulatory tasks
Module 2:
AI for Literature Searches and Research
(2 hours)
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AI-powered literature search techniques
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Database integration and automation
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Quality assessment of AI-generated results
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Documentation and traceability requirements
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Homework: Conduct AI-assisted literature search on assigned topic
Module 3:
AI for Content Creation and Documentation
(2 hours)
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AI tools for regulatory document drafting
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Quality control and review processes
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Maintaining regulatory compliance in AI-generated content
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Version control and change management
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Homework: Create regulatory document section using AI toolser review
Module 4:
AI Governance and Best Practices
(2 hours)
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Developing AI usage policies for regulatory teams
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Risk management for AI tool implementation
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Training and competency requirements
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Future trends and regulatory landscape
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Homework: Develop AI governance framework for regulatory department
