Development support

You have our support from the word go!

Are you planning the development of a new device and do you want to follow the correct procedure right from the start? We will support you with our expertise and know-how, ensuring that your new devices come to market as quickly as possible.

What we can do for you

• We support you in the strategic planning of CE marking or international marketing authorisation.
• We help you with the classification and demarcation of medical devices and medicinal products.
• We assist you with the implementation of a design control process in accordance with DIN EN ISO 13485 and 21 CRF 820.30.
• We advise you regarding reimbursement for or the usability of your medical devices in accordance with DIN EN 60601-1-6.
• We coordinate the external and internal testing of your devices.
• We communicate with your notified body and the competent authorities on your behalf.