We are now ISO 13485:2016 certified!

What does it Mean?

Synens received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Bureau Veritas Certification, highlighting that the company's quality management system meets the most current regulatory requirements specific to the medical device industry.

ISO certification explained

The Certification for effective Medical Device and Quality Management Systems

ISO 13485:2016 is an internationally recognised standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.

The certification represents an important milestone for our company, reflecting our rigorous approach to the design, manufacture, and distribution of our products.