Get audit-ready with free guides, detailed crosswalks, and an automated review of your QMS.
No consultants. No waiting. No implementation project.
Three steps to compliance clarity
Connect your Drive
Authorize read-only access to your Google Drive. We never store your documents — files are analyzed in-flight.
Every document is evaluated
Each document is scanned against 184 requirements across QMSR / ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 81001-5-1, FDA Cybersecurity, and FDA Postmarket Surveillance. Requirement by requirement, not keyword matching.
Get your gap report
A prioritized list of gaps with clause references, explanations, and recommended fixes. Start with what matters most.
More than a checklist.
A clear picture of where you stand.
Know what you have — and what’s missing
Your documents are classified as SOPs, work instructions, plans, records, and templates, then mapped against what each standard actually requires. You see your full inventory and the gaps in it.
Requirement-by-requirement evaluation
Every document is evaluated against specific clauses from the 7 standards that govern medical device quality. Not keyword search — the scanner reads the content and evaluates what each clause actually requires.
Prioritized gaps with recommended fixes
Missing procedures, incomplete coverage, legacy terminology, missing cross-references between standards — each gap comes with a clause reference, an explanation, and a recommended fix. Start with what matters most.
Compliance insight isn’t what’s expensive.
Doing the work is.
We publish a clause-by-clause crosswalk across six standards, practical guides on each, and a full scan of your documents that returns real findings with clause references. Most QMS vendors charge for this, hide it behind a sales call, or never publish it. We publish because anyone preparing for an audit deserves to see what their system is up against before they commit a dollar.
When you want us to do more of the work — per-document findings, prioritized fixes, remediation guidance — that’s where pricing starts.
Free guides and crosswalks.
Free scan of your QMS for gaps.
No credit card. No sales call. Report delivered by email.
Read-only access. Your documents stay in your Drive.