Changes in regulatory guidelines – clearly visible in the example of the "MDR" (Medical Device Regulation), represent a major challenge for many manufacturers in the healthcare industry. We are happy to support you in the approval and/or registration of your products so that you can quickly start marketing them. Rely on our in-depth regulatory knowledge and focus on the preparations for your market launch.
For us, dealing with complex regulatory issues is part of our daily business. We are specialists in all regulatory issues and ensure that your new product is quickly ready for the market. We have ISO 13485, ISO 9001 and ISO 15378 certifications and are also happy to handle the communication with the authorities required to obtain registration in the respective markets. We will gladly take over the preparation of the technical documentation as well as the regular review and updating of the registrations for you.