Quality Management according to EN ISO 13485
Our quality management system is certified according to EN ISO 13485.
Medical online offers and mobile applications in smartphones already play an even more important role and will do so in future. Depending on the function, software can also be used as a medical product and must therefore comply with the European Medical Device Regulation (MDR). Among other things, these require that "Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art."(MDR; Annex I Chapter I Sec. 1)
Requirements for Quality Management in Software Development
The standard EN ISO 13485 stipulates minimum requirements for the design and development, production and installation and maintenance of medical products and related services, including medical software.
EN ISO 13485 is compulsory not only for manufacturers of medical products but also for the companies that put them on the market. The quality management system is intended to permanently fulfil clients' requirements and the basic statutory conditions applying to medical products and related services.
Our Quality Management System is certified according to EN ISO 13485
TWT Digital Health is certified according to EN ISO 13485 and is hence approved for the development and operation of software and apps in the healthcare sector. We not only provide our clients with comprehensive advice, we even act as distributors on their behalf. We also receive support and advice by Prof. Dr Christian Johner from the Institute for IT in the Healthcare Sector in Konstanz. Together with the Johner Institute, we prepare services concerned with the certification of software as medical products.