Developing medical grade solutions…
… is a challenge for every producer. Every change, step and decision must be logged, monitored and evaluated. To address this in a comprehensive and detailed way harmonized standards help us deliver quality products and ensure the benefits for the end-users. Products in the medical domain are highly regulated. In the end – the benefit for the patient is the reason why we are all developing medical grade solutions.
Our mission is to ensure high-quality standards with every product for the benefit of the customer and the company. We seek constant improvement in quality and services to meet the high demands and expectations of our global customer base. We have an implemented quality management system and our products are certified.
We have an established and certified Quality Management System in accordance with the requirements of ISO 13485:2012.
CE certification for product ADORA Assistant™
Our product, Touchless Medical Image Software Management for Surgeons, has been assessed and certified according to European Medical Device Directive 93/42/EEC Annex II: CE 1304 by SIQ.