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/

As part of its commitment to manufacture high quality, reliable and innovative medical devices, Biosintex is pleased to announce the granting of new certificates for its quality management system and medical devices.

On October 12, 2018 Biosintex received from DNV-GL Business Assurance the new ISO ISO 9001:2015 certificate, thus advancing from ISO 9001:2008 to ISO 9001:2015 certification. Upgrading to ISO 9001:2015 certification indicates that the company’s quality management system remains aligned with the current regulatory requirements.

On November 1, 2018, Biosintex received from DNV-GL Presafe (Notified Body 2460) the new CE mark certificates for all of its medical devices, thus replacing the old CE mark certificates issued by OTDM (Former Notified Body 1868). New CE mark certifications indicates that the medical devices manufactured by Biosintex continues to satisfy the requirements of relevant European Directive MDD 93/42/EEC.

The new CE mark affixed on all of the medical devices starting November 1st will be CE2460. The medical devices manufactured until November 1st and bearing CE1868 mark remain valid and will be marketed until their expiration date.

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



Winner: UMF Carol Davila Bucharest, Medicine; Project manager: Univ. Dr. Bratu Ovidiu Gabriel; grant title: “Local histological changes pre and post-surgery in urinary incontinence effort in women”: 06.03.2018



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