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How it works

Seven phases. One path. Always know where you are.

Every device travels the same seven phases, whatever its class or market. Medica fills each phase with the documents your route requires, tells you what is blocked and why, and drafts with you.

  1. Intentcomplete
  2. Plancomplete
  3. You are here3Inputsin progress
  4. 4Outputsupcoming
  5. 5Verifyupcoming
  6. 6Validateupcoming
  7. 7Submitupcoming
1

Intended use & classification

Say what the device is for and who uses it. Medica proposes the class and route.

Intended use statement, device classification and regulatory pathway determination (21 CFR 807/814; MDR Annex VIII).
2

Design & development planning

Plan the work: who does what, the reviews, the standards you will follow.

Design and development plan describing activities, responsibilities and interfaces (21 CFR 820.30(b); ISO 13485 §7.3.2).
3

User needs & design inputs

Turn user needs into testable requirements, with risk and usability in view.

Design input requirements, risk management plan and use specification (21 CFR 820.30(c); ISO 14971 §4.4; IEC 62366-1 §5.1).
4

Design outputs & architecture

Produce the design: specifications, architecture, drawings, software, labeling.

Design outputs meeting input requirements and containing acceptance criteria (21 CFR 820.30(d); IEC 62304 §5.3–5.5).
5

Verification

Test that outputs meet inputs: bench, software, electrical safety, biocompatibility.

Design verification confirming outputs meet inputs with documented results (21 CFR 820.30(f); IEC 60601-1; ISO 10993).
6

Validation & clinical evidence

Show the finished device meets user needs in real or simulated use; build the clinical case.

Design validation under defined operating conditions on initial production units, including software validation and clinical evaluation (21 CFR 820.30(g); MDR Art. 61).
7

Transfer, submission & release

Assemble the submission, transfer the design to production, release the DMR.

Design transfer to production specifications and premarket submission (21 CFR 820.30(h); 21 CFR 807 Subpart E; MDR Annex II/III).

You decide

Classification, route, every gate and every signature are human decisions, each recorded with its rationale on the ledger.

Assist drafts

Medica Assist proposes text, criteria and traces, cites its sources, and flags gaps — labelled, reviewable, never final.

The ledger remembers

Append-only, hash-chained, exportable. What an inspector asks for is one click away, in the order it happened.