Free lifecycle evidence workpaper · No signupAI PMS, PMCF & Clinical Evidence Review
Paste post-market and clinical evidence together so the agent can test the lifecycle links that static templates miss: complaints to signals, signals to risk, PMCF to clinical questions, and findings to CAPA and reports.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste your device scope, PMS data, clinical evidence and planned outputs
Try an example
Paste a PMS plan, complaint/trend summary, vigilance and field-action data, literature-search status, PMCF plan or results, CER/PEP excerpts, PSUR/PMS report draft, and risk-file links.
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.
About this agent
What to paste for a useful review
State the device, variants, class, markets, time on market and exposure or sales denominators when available.
Add the PMS plan, complaint and vigilance summaries, literature status, PMCF rationale or results, CER/PSUR conclusions, risk changes and CAPA links.
- Does this generate a final CER or PSUR?
- No. It creates a structured evidence and gap workpaper that can support controlled authoring and review.
- Can I paste complaint counts without sales data?
- Yes, but rate and trend conclusions may be limited without a suitable denominator and time window.
- Can the tool decide that PMCF is unnecessary?
- No. It can review the rationale supplied and identify unanswered clinical questions, but the manufacturer must document and approve the final strategy.
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