How many controls does ISO 13485 have?

ISO 13485 contains 24 controls organized across 5 domains.

Where does ISO 13485 apply?

ISO 13485 is applicable in International. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does ISO 13485 map to?

ISO 13485 has control-to-control mappings with 474 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with ISO 13485 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

ISO 13485

Medical devices - Quality management systems.

Domains

ISO 13485: Organizational Requirements

ISO 13485: Physical Safeguards

ISO 13485: Technical Safeguards

ISO 13485: Administrative Safeguards

ISO 13485: Patient Data Protection

Frequently Asked Questions

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