MediENGINEER – Technology package, process model package and set of procedures for the software development for medical devices
by Andreas Wandenälis (comments: 0)
From June 28, 2017 until July 31, 2019, ProSign is working on the project MediENGINEER which is supported by the state of Saxony-Anhalt with means from the European Regional Development Fund.
The objective is to develop a highly specialized modular system which can be used for the development of software for medical devices based on graphical models.
The aim should be to determine how the graphical programming system iCon-L can be used for the software development in the field of medical technology to obtain a product that is suitable for the evidence of development processes and procedures according to DIN EN 62304:2016-10 and that also meets the requirements of the American FDA.
Background of this comprehensive approach is the fact that the development of software for medical devices must be carried out within the narrow limits and high requirements of this DIN standard.
This is a great cost factor for the manufacturers as the required verification management regarding architecture, design, implementation and test coverage is very expensive, if traditional programming languages are used.
The medical suppliers will be provided with a package including the following elements:
- Programming tool
- Test environment, Testing strategy
- Harmonized software components - ready to use
- Operating system (in agreement with the particular hardware configurations)
- Runtime environment
- Generalized functional components (Software units)
- Processes, methods, procedures
- Document templates
- Verification and validation
Hence, the package provides a homogeneous overall solution. This consequently ensures a safe design and a safe maintenance of software for medical devices in accordance with the requirements of the DIN.