Information about Brighter’s ISO 13485 certification.
On 20 June 2019, Brighter was certified under ISO 13485:2016 – the internationally recognized standard that defines the regulatory requirements for medical devices and related services in Europe. The standard is well established and accepted worldwide. ISO 13485 is based on ISO 9001, the more general certification for quality management systems. ISO 13485 includes additional requirements specific to the medical technology sector, and includes all stages of manufacturing – from design to production and maintenance – as well as related services. The certification means that the need for