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BioSynTech Malaysia Group Sdn Bhd
199701004244 (419740-A)
No 3-2, 3rd Floor,
N-Tatt Building,
Jalan TP 5, Taman Perindustrian UEP,
47600 Subang Jaya, Selangor

Tel: +6 03 7886 2682
WhatsApp/Call: +6 016 216 0492
E : info@bstmgroup.com

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EUROMEX | Certification for medical devices

EUROMEX | Certification for medical devices

Certification for medical devices

Euromex is now ISO 13485:2016 certified!

ISO 13485:2016

We are proud to announce that on top of our ISO 9001:2015 certification Euromex is now also ISO 13485:2016 certified.

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system in the medical device industry.

The ISO 13485:2016 certification demonstrates Euromex’s commitment to providing high quality products based on certified management processes and ensures best practices in everything we do.

Beyond the ISO 13485:2016 certification our bScope and Delphi-X Observer are now certified as Class 1 devices per EU Medical Device Directive (MDR Medical Device Regulation) 2017/745