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ANSI/AAMI/ISO 13485-2003

Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

Others Also Bought

Medical devices - Application of risk management to medical devices (and amendment)
Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
Quality systems-Medical devices-Guidance on the application of ISO 13485 and ISO 13488, 1ed
Document History
Included in Packages
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Amendments & Corrections
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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.