ISO 13485 · Gap Analysis
ISO 13485 Readiness Check
Answer straightforward questions about your Medical-Device Quality Management System. Uploading existing documents is optional. If you upload documents, we will review them free of charge and provide personal feedback on visible evidence and gaps. You receive an initial assessment immediately.
✓ Your answers and files stay on this device until you submit them.
QMS & scope
Are the QMS scope, regulatory role, product groups, sites and outsourced processes clearly defined?
Possible evidenceQMS scope, product overview or regulatory role descriptionPDF, Word, Excel, PowerPoint or image. Maximum 5 MB per file and 15 MB total.