Can I paste a folder listing?
Yes. Include document names, revisions and status; copied tables and mixed formatting are acceptable.
Free dossier evidence workpaper · No signup
Medical Device Dossier Gap Analysis
Turn copied folder listings, document indexes, revision notes, and evidence summaries into a practical dossier map. The agent checks current public framework sources and keeps missing evidence separate from confirmed nonconformity.
Map the supplied dossier
Start with the product facts and evidence you actually have.
Find revisions and contradictions
Separate supplied evidence, public sources, and assumptions.
Create an attachment worklist
Download a branded workpaper with gaps and next actions.
Map your dossier and missing evidence
The agent turns an unstructured document list into a source-aware dossier map, identifies contradictions and missing evidence, and separates existing, adaptable, planned, and absent content.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
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How to get a useful workpaper
- 1State the product, exact models, target markets and application type.
- 2Paste the dossier index with document names, revisions, status, scope and known open evidence.
Continue from this workpaper
Carry the same product context into a related search, evidence review, or planning task.
Medical Device Dossier Gap Analysis FAQ
Does it generate the missing documents?
No. It creates a prioritized evidence and attachment worklist and links into related preparation tools.
Can it compare two dossier revisions?
Paste both indexes with clear headings and revisions so the agent can identify additions, removals, stale references and conflicts.
Is the result a regulatory approval decision?
No. It is a preliminary workpaper requiring source-document and expert review.