Design your medical device.
Compliance comes built in.
Medica turns FDA and ISO design control into a guided path your whole team can follow: every Design History File document drafted with AI, reviewed by people, signed electronically and version-controlled — with the traceability auditors expect, from first sketch to submission.
Four steps from idea to a submission-ready file
You describe the device. Medica builds the regulatory path, generates the paperwork with you, and keeps every decision on an immutable ledger.
Describe your device
Intended use, technology, where you sell. Medica classifies it, proposes the pathway and the predicate landscape.
Get your roadmap
A seven-phase journey with every required document, its dependencies, owners and due dates — tuned to your class and standards.
Generate, review, decide
Medica Assist drafts with citations and shows its sources. Your experts accept, edit or reject. Gaps are flagged before reviewers see them.
Sign, file, submit
Part 11 signatures, controlled revisions synced to PostDocs, and an export that assembles your DHF, DMR and submission.
Regulatory roadmap
Always know where you are, what is blocked, and what to do next. Plain-language explanations with the regulation text one click away.
DHF dependency map
See how user needs flow into inputs, outputs, verification and the traceability matrix. Nothing ships with a dangling link.
Medica Assist
AI that drafts, cites and checks for gaps — and never decides, signs or files. Every machine-written paragraph is labelled and reviewed.
Electronic signatures & ledger
21 CFR Part 11 ceremonies with meaning, a WebAuthn-signed manifest and an append-only ledger you can hand to an auditor.
Version control with PostDocs
Effective revisions are immutable. Every change runs through a change request and lands in your PostDocs repository.
Workflow Studio
Start from Medica’s recommended process, then add your own steps, prompts and domain skills. Guardrails stay on the server.
Your first roadmap is twenty minutes away.
Create an organisation, describe one device, and see the full document map before you commit to anything.