Quality Management according to EN ISO 13485

Our quality management system is certified according to EN ISO 13485– a version of the quality standard ISO 9001 adapted for manufacturers of medical products.

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 Medical Products Guidelines (MPG). Among other things, these require that "the products must be designed and manufactured in such a way that (...) any risks must be reasonable compared with the useful effect for the patients and must be consistent with a high level of protection of health and safety".

Requirements for Software Products

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.

TWT Digital Health 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.

 

 

Klaus Mueller, Geschaftsführer xmachina

Your Contact Person

Klaus Mueller, CEO
+49 6221 8220 22

       

Certificate DIN EN ISO 13485