Due to extensive interest in Brighter’s ongoing certification process, we are issuing a status update as follows:
Brighter has been working in parallel on the certification of our quality management system under ISO 13485 (the framework for medical technology products), and on the CE-marking of Actiste. Both processes are carried out in collaboration with a Notified Body, which issues the relevant certifications.
ISO 13485 is a standard that ensures Brighter meets quality requirements for the design, development, manufacture and marketing of medical devices and services. The