Compliance standard
ISO 13485 templates
Policies, SOPs, plans, job aids, spreadsheets and decks aligned to ISO 13485, tailored to your organization in minutes.
Each ISO 13485 template is generated by AI around medical device quality management, design controls, CAPA and supplier qualification. You pick a document type, add your company details, and get a structured draft with purpose, scope, roles, procedures and review steps.
Use these documents to close gaps before an audit, show evidence to customers, or give staff clear instructions. Export to Word, Markdown or CSV and edit freely.
Policy
Information Security Policy (ISO 13485)Acceptable Use Policy (ISO 13485)Access Control Policy (ISO 13485)Data Retention Policy (ISO 13485)Data Classification Policy (ISO 13485)Password Policy (ISO 13485)Remote Work Policy (ISO 13485)Vendor Management Policy (ISO 13485)Change Management Policy (ISO 13485)Encryption Policy (ISO 13485)Privacy Policy (ISO 13485)Code of Conduct (ISO 13485)
Plan
SOP
Employee Onboarding SOP (ISO 13485)Employee Offboarding SOP (ISO 13485)Backup & Restore SOP (ISO 13485)Patch Management SOP (ISO 13485)User Access Review SOP (ISO 13485)Customer Complaint Handling SOP (ISO 13485)Document Control SOP (ISO 13485)Quality Inspection SOP (ISO 13485)Log Review Procedure (ISO 13485)Vulnerability Scanning Procedure (ISO 13485)