Glossary of Terms

ISO 13485

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The International Organizational for Standardization (1SO) 13485 represents a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 specifies requirements for a quality management system where an organization needs to establish its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements. Requirements of ISO 13485 are applied to medical devices.

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