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Decoding AI in software as a medical device (SaMD)
Key Takeaways
Bottom Line Up Front: Leading pharmaceutical companies are using AI-powered submission platforms to achieve 3x faster regulatory filings (from 31 weeks to 10 weeks), unlocking up to $180 million in net present value for billion-dollar assets while maintaining full FDA compliance.
What You'll Learn:
- Specific AI strategies used by top pharma companies to slash submission times
- How to achieve 8-12 week filing timelines with regulatory-grade AI
- FDA 2025 AI compliance requirements and implementation frameworks
- Step-by-step roadmap for AI submission transformation
Read our whitepaper to learn more about:
- AI in clinical applications, the difference between adaptive and locked AI
- The roles of AI in SaMD and AI in SiMD
- Regulatory insights, including references to IMDRF AIML and Good Machine Learning Practice (GMLP) for machine learning medical devices
- Real-world examples of AI in SaMDs, SiMDs, and broader medical device AI deployments