Classification Analysis
FDA Classification — Class II Medical Device (510(k) Required)
VerifiedIEC 62304 Safety Class — Class B: Non-serious injury possible
VerifiedIMDRF Risk Category — Category C: Moderate individual risk
VerifiedPurpose-built tools to help Software as a Medical Device companies navigate FDA compliance, generate documentation, and get to market faster.
SaMD companies spend up to 40% of their resources on regulatory documentation. Our AI-powered platform automates the evidence generation process so your team can focus on building life-changing products.
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Learn more about the medical device classification Decision Tree and understand your pathway.
Link to product roadmapAutomatically find and compare predicate devices to strengthen your 510(k) submission.
Automatically generate SOUP documentation from your dependency files and package manifests.
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See our product roadmapAverage reduction in regulatory documentation time
Faster classification decisions with guided workflows
Traceability from requirements to verification evidence
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