Infographic
A visual breakdown of how predictive extractables and leachables (E&L) testing with AI-powered modeling with Lumo™ eliminates response factor variation to deliver faster, more defensible chemical characterization for medical devices and combination products.
You’ll Learn How Lumo™ Helps:
- Predict compound-specific response factors using neural networks
- Reduce unnecessary calibrations and lower AET-triggered burdens
- Accelerate ISO 10993-18 compliant workflows with fewer “unknowns”
- Improve submission defensibility and reduce Additional Information (AI) requests
- Cut lab timelines from 22 weeks to as little as 4 weeks in select programs
Who Should Read:
- MedTech manufacturers and combination product developers navigating ISO 10993-18, chemical characterization, or E&L compliance
- Regulatory, Quality, and Lab leaders
- Preclinical, Product Development, Clinical Affairs, and Program Management teams who are responsible for submission strategy, testing timelines, or toxicology defensibility
The Outcome:
A predictive, lab-to-toxicology blueprint that reduces E&L uncertainty, accelerates chemical characterization, and strengthens submission confidence.
Download the infographic to see how smarter predictions mean faster programs.
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