The EU regulates the conditions under which products with a medical purpose may be placed on the market. This serves to protect the patient and is intended, for example, to ensure that products are effective and do not involve any disproportionate risks. Manufacturers are required to place the CE mark on their products to show that their products meet applicable safety and performance requirements.
We, Tech & Life Solutions GmbH, have developed our App Harmony taking into account the applicable standards for quality management as well as for the processes of risk management, software life cycle and usability and are responsible for supporting the app accordingly. Harmody is a risk class I medical device according to the Medical Device Regulation (MDR) European regulation for medical devices.