The Biolux team is fully committed to quality at every level of the company. This allows us to offer innovative, effective, high-quality products designed to meet market needs and fulfil applicable safety regulations.
Biolux guarantees its devices and treatments are safe and conform to applicable regulations. But we don’t stop there: we work to continuously improve and anticipate potential institutional barriers.
Our professional products have been approved around the world:
ISO 9001 and ISO 13485 are international standards on quality management systems.
Instruments with the CE marking conform to essential requirements defined by the 14 June 1993 directive 93/42/CEE concerning medical devices (recently amended by the 2007/47/CE directive). CE marking guarantees that using the device will not compromise a patient’s clinical state or safety, or the safety and health of users. It is understood that potential risks linked to using the device constitute acceptable risks in relation to the benefits a patient receives and are compatible with a high level of health and safety protection.
The Food and Drug Administration (FDA) is the American federal agency governing the healthcare and food industries. FDA approval is required for all medical devices in the United States.