03/03 - 2024

ExamVision is
ISO 13485 certified

Medical devices manufactured by ExamVision meet the requirements according to EN ISO 13485:2016

ExamVision has achieved the global quality certification of our Quality Management System according to EN ISO 13485:2016. 

EN ISO 13485:2016 certification warrants that the internationally agreed-upon set of standard quality requirements is met. Specifically designed for companies involved in the design, production, installation, servicing, and manufacturing of medical devices. 

This quality standard confirms that ExamVision is able to comply with requirements and regulations demonstrating that end-users and patients may confirmed their quality expectations for the features and performance marketed for the individual products. 

Obtaining the globally recognised ISO standard certification for medical devices is an important milestone for ExamVision.  

2024 03 News ISO 2