No cost entry · Same Cruxi app
Free QMSR / ISO 13485 readiness scan for medical device teams
FREE: Start with a free readiness scan to understand QMS maturity, likely gaps, and missing documents from structured intake—before you pay for document-backed deep analysis or bring in consultants.
Run free scan on this pagePrefer the app? Continue in Cruxi for the same scan plus paid deep analysis.
Preliminary, intake-led orientation only. Not an FDA inspection, ISO certification audit, legal opinion, or substitute for qualified expert judgment. QMSR effective February 2, 2026; incorporates ISO 13485:2016 by reference.
Free readiness scan
Same intake logic as the in-app free step: answer the prompts, then download a text summary. For document-backed deep analysis and expert review, continue in the app—no changes were made to that workflow.
What you get in the free scan
Intake-based orientation for SEO and campaigns. Paid deep analysis and expert review stay in the Cruxi app when you are ready.
Intake-based visibility
Structured questions map to QMS maturity, likely gap areas, and missing SOPs or evidence—so you see where you stand before deeper work.
Clear upgrade path
When you need evidence-backed gaps, a readiness package, and drafts, upgrade to paid deep analysis in the same app. Optional expert review comes later if you want validation or remediation support.
What the free scan is not
- closeNot a full review of uploaded QMS files—that is the paid deep analysis stage.
- closeNot certification, not a regulatory guarantee, not an inspection outcome.
- closeNot a replacement for your quality owner or a qualified consultant for formal decisions.
FAQ
Short answers for organic and paid traffic landing on this page.
What is included in the free QMSR readiness scan?
An intake-based entry point: early visibility into QMS maturity, likely gaps, and missing documents. It is not a substitute for document-backed deep analysis or expert validation.
Where do I run the scan?
Use the embedded scan on this page for an instant summary, or open cruxi.ai/510k-new for the same free step inside the app plus paid deep analysis.
Can I start free and decide later?
Yes. Use the free scan first; upgrade to paid deep analysis only if you want document-backed findings and a structured package. Expert review is optional after that.
What is QMSR?
QMSR is FDA's Quality Management System Regulation for medical devices, effective February 2, 2026, incorporating ISO 13485:2016 by reference.