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Regulatory Service
Device Classification
Know your risk class before you invest in a pathway.
Overview
We determine the correct risk classification for your device across each target market, using rule-based analysis and predicate comparison. Accurate classification defines your regulatory pathway, evidence requirements and timelines.
What's included
- Rule-based classification per FDA, EU MDR, Health Canada, TGA, CDSCO and more
- Intended-use and indications-for-use definition
- Predicate and equivalent-device analysis
- Classification rationale documented for submission
Get Started
Tell us about your device and target markets.
Share your device and regions of interest and our team will respond with a tailored regulatory outline within two business days.