Can it review draft study protocols?
Yes. Clearly mark protocols versus completed reports so planned evidence is not mistaken for results.
Free IVD performance workpaper · No signup
IVD Analytical Performance Evidence Review
Paste study protocols, report summaries, claims, specimen instructions, calibrator information, stability evidence, and open items. The agent identifies missing elements and cross-document contradictions without inventing results or acceptance criteria.
Map every analytical study
Start with the product facts and evidence you actually have.
Find contradictions and missing scope
Separate supplied evidence, public sources, and assumptions.
Connect evidence to claims and labeling
Download a branded workpaper with gaps and next actions.
Review an IVD analytical performance evidence package
The agent maps analytical evidence, inconsistencies, missing study elements, and dependencies without inventing acceptance criteria or results.
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
- 1Describe the analyte, intended purpose, specimen, users, setting, platform, target markets and claims.
- 2Paste protocols and report summaries with status, sample/lot/site scope, acceptance criteria, conclusions and labeling links.
Continue from this workpaper
Carry the same product context into a related search, evidence review, or planning task.
IVD Analytical Performance Evidence Review FAQ
Does it support qualitative and quantitative assays?
Yes. State the assay type and claims so non-applicable areas can be handled conservatively.
Will it invent sample sizes or acceptance criteria?
No. Missing values are identified as questions or gaps.
Can it review clinical performance too?
It checks analytical-to-clinical links and open clinical evidence, but it is not a complete performance evaluation report.