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QMS & Conformity Assessment Package

Describe the system, its classification, the conformity assessment route (Annex VI internal control vs Annex VII notified body), your organization's existing controls and certifications. Get a QMS outline, a technical documentation checklist, and questions for the notified body and legal counsel.

✓ Leverages existing ISO 9001 / 27001 / 42001 instead of building parallel structures✓ Internal control (Annex VI) vs notified body (Annex VII) framing✓ Adaptable to FDA SaMD, FINRA, and sector-specific quality regimes

Results in ~45 seconds · Saves ~3 days per system

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