Software in Accordance with MDR, IVDR and FDA
For software to be used in medical products and laboratory equipment or as a standalone medical product (e.g. medical apps), it must be developed in accordance with legal requirements. From the idea stage through to certification, infoteam is your development partner for standard-compliant software in accordance with MDR, IVDR, FDA and NMPA. You can also benefit from our extensive experience and avail of our support to ensure seamless collaboration with other suppliers.
As an experienced development partner, infoteam has had a certified quality management system according to ISO 13485 for many years. This includes our development process iSOP.medical, which fulfills the relevant requirements of IEC 62304. It is designed for agile software development (e.g. Scrum) and includes risk management according to ISO 14971 and usability engineering according to IEC 62366-1, as well as templates and processes for the development and distribution of software as a medical product in class I to III (or IEC 62304 safety classes A to C). The relevant standard IEC 82304 for standalone software is also covered. In light of the increasing interconnectedness of medical products, the iSOP.medical development process also guarantees appropriate cyber security for your applications and the surrounding system. In this way, we can ensure that your software complies with standards for use worldwide – in the new development of software in laboratory and medical devices, as well as in the maintenance and modernisation of legacy software on long-established legacy systems.
If you have your own development process, we would also happy to use this for the development of your software.