News

Upgrading ISO 13485 certification

Biosintex announces the new ISO certification 13485:2016 granted by the prestigious notified body DNV GL Presafe As.

ISO 13485:2016 is the most current international quality system standard designed specifically for medical device companies.

This upgrading of certification from previous version ISO 13485:2003 to the new one indicates that Biosintex continues to demonstrated the ability to provide medical devices that consistently meet customer and regulatory requirements.

All current quality certificates (ISO 9001, ISO 13485 and EC certificates for all medical devices) can be viewed and downloaded from page https://www.biosintex.com/certificari/