As an alternative to stand-alone software, there are IVD medical devices in which the software is an integral part of the device, so-called embedded software.For software in a device (“embedded” into the device, e.g. as firmware), the difficulty is to align the development process both to the overall system and the requirements of software development and provide for a seamless transition between hardware and software.As a holistic service provider we support you in all regulatory tasks of the development process.We cleverly interweave the aspects of information security with the process so that your networked devices comply with the current IVDR requirements.Talk to us about how we can guide the development of your embedded software safely through all regulatory requirements – from the first idea to full IVDR compliance.Get in touch with us today
For small and medium-sized enterprises it is often rather difficult to develop regulatory competence about software. Let’s find out together whether your software is documented correctly.
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