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 13485:2016 is to facilitate medical device regulatory requirements for this quality management system and the primary objective for ISO 9001:2015 is to facilitate general manufacturing regulatory requirements for this quality management system. All requirements of ISO 13485:2016 and ISO 9001:2015 are specific, regardless of the type or size of the organization.
OXID Corporation is committed to the highest level of quality. We will continually improve while maintaining 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.