Device background Dossier

Public-data research inputs, organised the way a design history file consumes them

Loading the published catalog…

This produces a research input, not a risk management file. ISO 14971 requires the manufacturer's own acceptability criteria, risk estimation and benefit-risk judgment; none of those can come from public data and nothing here supplies them. The P1 and P2 columns in the exported hazard table are blank on purpose — MAUDE has no denominator, so probability of occurrence cannot be derived from it.

1 · Predicate product codes

Only codes with a published slice appear here. Ask for another on the feed page.

2 · Device profile — stays in this browser

Status New device Already marketed

Class, if known

Characteristics

Intended use (optional)

Device description (optional)

Key differences from the predicates (optional)

These fields are used to label the document and are written into the file you download. Nothing here is sent anywhere — the only requests this page makes are for the public artifacts under /api/maude/v0/.

3 · Modules

M1 — Post-market hazard evidence M2 — Data quality statement M3 — Claims-to-evidence matrix (CER shape; the claims are yours) M4 — PMCF plan skeleton (MDCG 2020-7 headings) M5 — Post-market summary in FDA terms (MDRs by event type and quarter, recalls with root cause)

The literature rows in M3 are filled from a documented search; the literature search page produces the protocol, the screening log and the PRISMA count.

Later modules (standards applicability, predicate testing precedent, clinical search record, user-need prompts) are specified and not built.

4 · Review record

The exported file carries its own review record: your name, your disposition of each statement below, the snapshot and the method versions. Nothing you type is sent anywhere — it is written into the file and nowhere else.

Reviewer name

Organisation

The Dossier is assembled and written in your browser so that the device profile never leaves it, which needs JavaScript. The underlying data is on the feed page and at /api/maude/v0/ either way.