Free FDA QMSR readiness review · No signupAI FDA QMSR Evidence Gap Review
Review how your quality system actually operates under the now-effective FDA QMSR. The agent looks beyond a paper crosswalk and tests whether current records demonstrate implementation and inspection readiness.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste your QMSR transition and implementation evidence
Try an example
Paste your QMS scope, transition crosswalk, procedures, audits, management review, risk controls, supplier records, complaint/CAPA evidence, software validation, and inspection-readiness material.
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
Include the manufacturer and device scope, sites, outsourced processes and your QMSR/ISO 13485 crosswalk or transition summary.
Add recent management review, audits, supplier evidence, risk links, complaint/CAPA records, electronic-system validation and inspection-readiness samples.
- Is QMSR already effective?
- Yes. FDA states that QMSR became effective on February 2, 2026 and FDA began using its updated medical-device manufacturer inspection process.
- Is an ISO 13485 certificate enough?
- No. A certificate does not by itself demonstrate every FDA-specific requirement or effective implementation at all relevant sites and processes.
- Does this reproduce ISO 13485?
- No. It uses independent, high-level review areas and does not replace a licensed copy of the standard.
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