Free tools
Free tools for medical device software teams
Quick first-pass answers to the questions I get asked most, built on the standards and FDA guidance I work with every day. The on-screen result is free; a branded PDF report is one short form away.
IEC 62304
Software safety class calculator
Five questions, your likely software safety class (A, B or C), and the lifecycle deliverables that class calls for.
Start →FDA premarket
Documentation Level evaluator
Basic or Enhanced? Five questions, your likely FDA software Documentation Level, and what it changes in the submission.
Start →Run both: the IEC 62304 class counts risk controls outside the software, and FDA's Documentation Level doesn't, so the two answers can differ. Want the templates that go with them? Get the free templates.