Free tool
Compliance readiness score
Eight questions. Find out how audit-ready your QMS actually is -- and exactly where the gaps are.
This covers what a notified body, FDA reviewer, or enterprise procurement team will look for: requirements, traceability, test evidence, risk analysis, release records, and more.
Ready?
Answer based on what your QMS can actually produce today -- not what you plan to have in place. Takes about two minutes.
This is a general readiness check, not a certification. Scores reflect common audit expectations under ISO 13485 and IEC 62304.
Your score
Your gaps
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Strong position
Your QMS is in good shape.
You have most of the foundations in place. The remaining gaps are worth closing before your next audit or enterprise sales process -- they are the items auditors check last and flag loudest when missing.
Focus on the gaps listed above. If you are using QualiHQ, these are manageable within a single sprint.
Making progress
You have the foundations. The gaps will hurt at audit time.
A partial QMS is better than nothing, but auditors and enterprise buyers will find the gaps quickly. The items you are missing are not edge cases -- they are the core of what a QMS audit checks.
The good news: the remaining gaps are buildable. Most teams close them within four to six weeks with the right tool in place.
Getting started
Your QMS is not ready for an audit today.
That is common at this stage -- most regulated software teams underestimate how early they need to start. The records you need to produce do not just need to exist; they need to have been built up over time as evidence of your actual development process.
Starting now, before your first enterprise sale or notified body conversation, is significantly easier than reconstructing records retroactively. Every sprint from here can generate compliant artefacts.
Close the gaps with QualiHQ
QualiHQ generates your requirements, verifications, traceability, and release records from your existing documentation. Free to start, no credit card.
Get started free →Build your QMS in days, not months.
Paste your README or design doc. QualiHQ generates your requirements, test verifications, risk analysis, and release workflows. Everything an auditor or enterprise buyer will ask for -- built as you ship.
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