Software in your IVD: Embedded software

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.

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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Harmonized standards under the IVD directive 98/79/EEC

EN 62304
Defines the life cycle requirements for medical device software. The series of processes, activities and tasks described in this standard provide a common framework for life cycle processes of medical device software.

EN 61010
The EN 61010-x (“Safety requirements for electrical equipment for measurement, control, and laboratory use”) series of standards classifies IVD medical devices as equipment for “laboratory use”. In this series of standards, the specific part EN 61010-2-101 for “in vitro diagnostic (IVD) medical equipment” substantially regulates the electrical and mechanical safety of IVD medical devices.

EN 61326-2
The electromagnetic compatibility (emission and immunity) requirements for in vitro diagnostic medical devices are described in the harmonized standard EN 61326-2-6.

EN 60601-2-x
The EN 60601 series of standards defines safety and ergonomic requirements for medical electrical equipment and in medical systems. This series of standards may be consulted, however, is not harmonized for IVDs.

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