ISO 9001:2015 & 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 9001:2015 & 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 9001 & 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.
OXID Corporation is committed to the highest level of quality. We will continually improve the effectiveness of our quality management system through product quality, compliance to all applicable regulatory requirements, international standards and customer requirements throughout all aspects of development, manufacturing, sales and the life of the product.