i2a automated systems are ISO 13485:2016 certified.
This standard specifies the requirements for quality management systems where an organisation needs to demonstrate its ability to provide a regular supply of medical devices and related services that are compliant with both customer requirements and those of the applicable regulations.
Every step in the life cycle of our automated systems (design and development, production, storage, distribution, and installation) complies with the standard. The same applies to the design, development, and provision of the related services (e.g. technical support).