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.