After a successful audit for its quality management system, Neofonie received ISO 13485 certification from TÜV Hessen.
ISO 13485 certificate
With the ISO 13485 certification, Neofonie meets the requirements of the Medical Device Regulation (MDR) in Europe and is authorized to design and implement medical apps and software as medical products in compliance with the standard.
The Neofonie Group has been developing innovative software solutions for the healthcare sector for more than ten years. With the entry into force of the Medical Device Regulation (MDR) of the European Union, the regulatory requirements for medical devices have increased. For manufacturers of medical devices from risk class II, compliance with the ISO 13485 standard applies. This applies to both software as a medical product and medical apps. The MDR regulates the conformity assessment of medical devices including medical software and explicitly requires a quality management system to ensure the safety and quality of the products.
To meet European standards, the Neofonie Group has adapted its quality management to the ISO 13485 standard. “The medical industry has always been an essential core area of the Neofonie Group. With the certification, we create a fundamental prerequisite for being able to design and develop software as a medical product in order to be able to make a corresponding contribution to solving the upcoming challenges of the healthcare market and the associated benefits of digitization. With the certification, TÜV Hessen confirms the high quality standards that we meet in the areas of usability, software development and maintenance,” explains Thomas Kitlitschko, Managing Director of the Neofonie Group.
However, the challenges in the healthcare sector have not only increased due to increased regulations. In order to ensure patient care in times of staff shortages, especially in rural areas and under increasing cost pressure, and to make the healthcare system more efficient, the federal and state governments are pushing ahead with the expansion of digitization. “When developing e-health solutions, user expectations in terms of usability, accessibility and data protection must be taken into account. As a specialist for health applications and user-oriented software products, we have the necessary experience and support companies in setting up and expanding their digital strategies and solutions,” Thomas Kitlitschko continues.
For this purpose, Neofonie has strengthened its staff and set up a UX and developer team focused on e-health, including a project manager with many years of e-health expertise. In addition, the new quality management officer accompanies the healthcare projects, taking into account the current regulations and safety requirements.
The Neofonie Group develops individual and user-centric solutions in the areas of mobile, commerce, content and artificial intelligence. Together with the AI agency ontolux, the UX agency ION ONE and the subsidiary Neofonie Mobile, which specializes in mobile solutions, it offers consulting, design, development and operation from a single source. Customers include Wort&Bild Verlag, HUK-COBURG, curacado and the AO Foundation. Neofonie was founded in 1998 with the development of the first German search engine, Fireball, as a spin-off from the TU Berlin. (www.neofonie.de)
company contact
Neofonie GmbH
Anja Unterberger-Schneck
Robert-Koch-Platz 4
10115 Berlin
030246270
Press contact
Neofonie GmbH
Anja Unterberger-Schneck
Robert-Koch-Platz 4
10115 Berlin
030246270