Software development and approval in biomedical engineering

You develop software as a standalone medical device or as part of a medical device. We will support you to secure conformity to existing standards.

As a software development partner, MedSysCon provides a software development process that reflects the full software-lifecycle of IEC 62304. For sure we also consider the topics risk management, clinical evaluation and usability as well as verification and validation of software.

We will support you during the software development and the preparation of the technical documentation including the risk management process and the usability engineering file for medical software.

IEC 62304

Software Development according to the accepted standard

Your Benefits

We will support you in the creation of a fully compliant software documentation that will allow you to pass each audit and get approval for your medical device.

Do you have questions on the subject Software Development?

We will be happy to provide you with comprehensive advice.

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