As a medtech company, compliance with the requirements of the European Medical Device Regulation (MDR) is a legal obligation for us and essential in order to be allowed to bring products onto the market at all.

While many of our competitors are still using the transitional provisions of the MDD, we have already fully converted to the MDR in 2023 and successfully had our software for dermoscopy and total body mapping, supported by KI, certified as Class IIa products. 

FotoFinder therefore not only fulfills the legal requirements of the MDR, but also sets standards in terms of safety and performance. In addition to MDR certification, we also have a certified quality management system in accordance with ISO 13485. You can rest assured that our products meet the highest standards and are subject to continuous further development: Cutting-edge technology you can rely on!

The Notified Body TÜV SÜD Product Service GmbH confirmed in 2023 that our quality management system meets the requirements of the EU MDR Regulation 2017/745.
Regular monitoring and evaluation of the technical documentation ensures that the highest requirements are continuously met in the clinic and practice. 

Our decision to focus directly on the new standards underlines our commitment to the highest quality, future-proofing and innovative strength - and offers you as a customer the security of being able to rely on state-of-the-art and reliable products.

According to Article 5 of the Medical Device Regulation (MDR), doctors are obliged to ensure that medical devices meet the requirements of the MDR and are correctly CE-marked when selecting them. They may only use medical devices that demonstrably comply with the applicable legal requirements.