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BIOSINTEX PARTICIPATES AT ARAB HEALTH 2020

BIOSINTEX PARTICIPATES AT ARAB HEALTH 2020

BIOSINTEX participates at Arab Health, the largest medical exhibition in the Middle East, which takes place in Dubai, 27th- 30th January 2020. Please, visit us at BOOTH Z5.B41. more


BIOSINTEX PARTICIPATES AT MEDICA DUSSELDORF 2019

BIOSINTEX PARTICIPATES AT MEDICA DUSSELDORF 2019

BIOSINTEX participates at Medica - World Forum for Medicine, which takes place in Dusseldorf, Germany, 18th-21th November 2019. Please, visit us at BOOTH 70C01/HALL 7.0STAND C1/HALL 7. more


Upgrading ISO 13485 certification

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/

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Biosintex Certificates

Biosintex Certificates

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/

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Competition to award a scientific research grant

Competition to award a scientific research grant

BIOSINTEX SRL, represented by Alin Iosif, launches a new grant for scientific research during the period 14.02.2018 - 23.02.2018.

Documents and procedure for submission are available on site, www.biosintex.com, and in attachments.

Calendar competition:

. Launching the competition: 14.02.2018
. Submission: 14.02.2018- 23.02.2018, 10:00am
. Verification of eligibility and evaluation: 28.02.2018
. Displaying results: 01.03.2018
. Filing appeals: 02.03.2018, until 14:00pm
. Validation of results: 05.03.2018
. Communication of Results (name of institution, name of project director, title of grant and the scored obtained): 06.03.2018
. Signing the contract: 07.03.2018- 09.03.2018
. Carrying grant:12 months from signing of the financing contract with the possibility of extension in exceptional cases up to maximum of 6 months

Read the competition rules

If you agree to the terms and conditions of the Regulation please download the following documents:

Application for funding
Declaration of conflict of interests
Assesment report

Submissions

Displaying results

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BIOSINTEX PARTICIPATES AT MEDICA DUSSELDORF 2018

BIOSINTEX PARTICIPATES AT MEDICA DUSSELDORF 2018

BIOSINTEX participates at Medica - World Forum for Medicine, which takes place in Dusseldorf, Germany, 12th-15th November 2018. Please, visit us at BOOTH 70C01/HALL 7.0STAND C1/HALL 7. more


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