Software in medical devices: embedded software

As an alternative to stand-alone software, there are 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 (60601-1) and the requirements of software development (IEC 62304) and provide for a seamless transition between the components (hardware/software). Also, the issue of system integration needs special attention.

AAs 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 MDR requirements.

Software is by now used in almost any active device. Often, we discover that it is not documented correctly. Let’s find out together whether your software is documented correctly.
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Regulations and standards

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

IEC 60601-1
Applies to the basic safety and essential performance of medical electrical devices and medical electrical systems for use in home care.