Does this generate a final CER or PSUR?
No. It creates a structured evidence and gap workpaper that can support controlled authoring and review.
Free lifecycle evidence workpaper · No signup
AI 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.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Inventory lifecycle evidence
The agent separates supplied facts, documents, assumptions and unknowns.
Review signals and clinical gaps
Every finding stays tied to the evidence you actually supplied.
Connect PMS, risk, CAPA and CER
Turn the result into a practical worklist and save it as a branded PDF.
Review your PMS, PMCF and CER evidence
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 save this pasted text or the generated report. The text is sent to our AI provider for this one-time analysis. Avoid confidential information you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
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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.
Continue your regulatory workflow
Move from this workpaper into the next connected review. Pasted evidence stays on this page and is never placed in a link.
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Complaint & FSCA Workpaper
Screen incident facts, reporting paths, health risk, field actions, and communications
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AI Risk Management File Review
Review hazards, controls, verification, residual risk, traceability, and post-market updates
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AI CAPA Investigation Builder
Structure containment, root-cause hypotheses, actions, effectiveness, and risk linkage
Frequently asked questions
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.
What makes this different from a template?
It evaluates the actual text and data you paste, distinguishes evidence from plans, and checks links among PMS, clinical evaluation, risk management and CAPA.