Platform
One workspace from intended use to submission.
Medica is organised the way an auditor reads a Design History File: a journey of phases, each with required documents, each document with a controlled revision, each revision with its signatures and its place in the dependency map.
Regulatory roadmap
Describe the device once. Medica proposes the classification and the route (510(k), De Novo, PMA, MDR class), shows every derivation step with its citation, and lays out the seven phases with the required documents in each. You confirm or override — with a recorded rationale.
DHF dependency map
A live graph of user needs → design inputs → outputs → verification → validation, with the traceability matrix as its spine. Each node carries its revision and status; a blocked edge shows exactly which upstream document is holding the work.
Medica Assist
Drafts sections from your facts and your knowledge spaces, with inline citations and gap findings. Every machine-written paragraph is labelled "Assist draft" until a person accepts it, and Assist can never sign, release or file anything.
Controlled revisions with PostDocs
Effective revisions are immutable and synced to your PostDocs repository as signed commits. A change request opens a draft, the diff is reviewed, signatures are collected, and the release carries the new revision and its generated PDF.
Workflow Studio
Begin from the recommended process for your route. Add stages, gates and generation steps; attach prompts and domain skills; run with gates that stop and ask a person to proceed, hold or rework.
Process control & monitoring
Runs, gates, locks and refusals in one view, with the evidence ledger’s head hash on screen. Export the ledger as CSV for an inspection in one click.
Knowledge spaces
Upload predicate labeling, standards and literature. Assist cites them; the resolver never treats them as evidence. Search spans your documents and your uploads with a knowledge-graph walk.
Seven languages, one record
English, Arabic (RTL), German, French, Spanish, Chinese and Portuguese. Interface text follows the user; regulatory quotations stay in their source language; the ledger records in one language.