MDR Annex XIV · MEDDEV 2.7/1 Rev 4Live in the platform

Clinical Evaluation (CER / CEP)

Clinical evaluation from plan to report: a sealed search protocol, a screened literature record, appraised sources, and a CER that cannot outrun its evidence.

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The literature screening workspace in Complya: an arrivals list with screening statuses and a decision form with include, exclude and unclear options, protocol criterion reference and reasoning — The screening workspace: every include or exclude decision cites a protocol criterion and is appended to the record, never edited. Synthetic example data.

STEP 1

Plan and seal the protocol

The Clinical Evaluation Plan defines the search strategy. Sealing freezes it as an immutable revision the record is pinned to.

STEP 2

Search, screen, appraise

Executions are attested by the expert. Results are deduplicated, screened for inclusion, and appraised source by source.

STEP 3

Conclude and seal the CER

The structured conclusion is drawn from the appraisals, and the report is drafted against the requirement sets, reviewed and sealed.

What the workflow does

As shipped. Every line below is live in the platform today.

Structured literature-search protocols drafted from your case documents and sealed as immutable revisions.

AI proposals grounded only in your own documents; every citation is verified verbatim against the source before it is kept.

Search executions recorded as expert attestations, pinned to the exact sealed protocol they ran under.

Literature screening with identifier-based deduplication; near-duplicates are decided by the expert, never auto-merged.

Per-source appraisals of relevance, quality and contribution, each recorded with reasoning.

The structured clinical conclusion is built from the appraisals and feeds the CER's seal, so the report cannot assert a conclusion that was never made.

CER coverage tracked against MDR Annex XIV and MEDDEV 2.7/1 Rev 4 requirement sets, gap by gap.

THE SAME TRUST LAYER AS EVERY COMPLYA WORKFLOW

Sealed, not saved

Reviewed documents freeze as immutable revisions. A content-addressed seal binds the text to its inputs and every approved resolution.

Append-only history

Decision history cannot be edited from the application; corrections append as new records, never overwrite.

Grounded drafting

AI citations are verified verbatim against the cited source. A quote that cannot be located is dropped, never kept.

See it on your own device. Thirty minutes, no slides.

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