DGS Regulatory Affairs EN

The Regulatory Affairs and Compliance Department is responsible for obtaining and maintaining medical device registration certificates worldwide. We are active in countries where local regulatory authorities require manufacturers such as ours to obtain specific authorisation before a product can be placed on the market.

Our tasks also include monitoring changing legal regulations concerning diagnostic devices and creating documentation that meets the legal requirements of individual countries.

By ensuring compliance with international standards, our products have the opportunity to reach a specific market in line with customer demand.