The compliance review that used to take a consultant three weeks. Ready in minutes.
A requirement-by-requirement review of your quality system. 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 37 ISO 13485 clauses with QMSR overlay. 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 ISO 13485 document requirements. You see your full inventory and the gaps in it.
Requirement-by-requirement evaluation
Every document is evaluated against specific ISO 13485 clauses with QMSR overlay. 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 Part 820 terminology, missing cross-references — each gap comes with a clause reference, an explanation, and a recommended fix. Start with what matters most.
Free compliance review.
Pay only for the detailed report.
No credit card. No sales call. Results in minutes.
Read-only access. Your documents stay in your Drive.