It is paramount for us to serve our customers with safe, tested and reliable products. Our operations are guided by the common quality goals of the entire Group.
As a responsible corporation, we comply with international standards, regulatory requirements and local laws in various countries for medical device manufacturers, developers and service providers.
Our quality organization is responsible for measuring the Group's processes and set quality objectives, acts as an advisor and applies for and manages marketing authorizations worldwide. An essential part of our quality is knowledge of legislation and product and safety requirements and monitoring their development.
In all our operations, we comply with the ISO 13485 quality system (Medical devices – Quality management systems – Requirements for regulatory purposes) based on the principle of continuous improvement.
We have an MDSAP certificate that covers ISO 13485 as well as the requiremnts of participating regulatory jurisdictions which are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW) and the United States (FDA).