Biolux is ISO 9001 and ISO 13485 certified
ISO 9001 and ISO 13485 are international standards relating to quality management systems:
- ISO 9001 specifies and validates design processes and commitment to continuous improvement
- ISO 13485 specifies regulatory requirements for quality management systems related to the medical device industry.
The Biolux device has the CE MEDICAL
Instruments bearing the CE marking comply with the essential requirements defined by Directive 93/42/EEC relating to medical devices of 14 June 1993 (last amended by Directive 2007/47/EC). CE marking guarantees that use of the device does not compromise the clinical condition and safety of patients or the safety and health of users, it being understood that any risks associated with its use constitute acceptable risks in relation to the benefit provided. to the patient and compatible with a high level of health and safety protection.
The Biolux device is FDA approved (name ELYX)
The FDA (Food and Drug Administration) is the US federal agency for health and food. FDA approval is mandatory for all medical devices in the United States.
