Identify your pathway
Build a clearer understanding of device classification and the product code appropriate to your product.
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What we do
Greater clarity for the decisions behind an FDA 510(k).
ComplyBean helps early-stage medical-device teams navigate classification, product code, predicates, and supporting evidence without building an in-house regulatory team.
Pathway
Predicate
Testing
Evidence
One connected
regulatory case
regulatory case
Connected guidance
Four decisions. One regulatory story.
Each decision affects the next. ComplyBean helps your team follow those connections instead of assembling an answer from disconnected documents and searches.
Study the landscape
Explore relevant predicate devices, standards, guidance, and comparable products without losing the thread.
Know what to prove
Translate regulatory expectations into a practical plan for testing, clinical evidence, risk, and documentation.
Stay on track
Surface inconsistencies and evidence that may no longer align as your product and regulatory case evolve.
Describe
Product context
Explore
Pathway reasoning
Decide
Human judgment