Glossary of Terms
ISO 13485
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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