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.
Free FDA QMSR readiness review · No signup
AI 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.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Inventory transition evidence
The agent separates supplied facts, documents, assumptions and unknowns.
Review implementation records
Every finding stays tied to the evidence you actually supplied.
Prioritize inspection gaps
Turn the result into a practical worklist and save it as a branded PDF.
Review your FDA QMSR readiness
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 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
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.
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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Map a submission evidence index to missing sections, attachments, and technical-screening risks
Frequently asked questions
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.
What evidence is most useful?
Recent operating records—audits, management decisions, supplier monitoring, complaints, CAPA effectiveness, risk updates and validated-system changes—are more useful than procedure titles alone.