Software for Medical Devices
Modern medical devices, such as operation robots, X-ray equipment, or laboratory equipment for in-vitro diagnostics consist primarily of software. For such medical products to be approved, it is essential for the medical product software to be developed in compliance with applicable standards and laws. In the scope of medical devices, these are standards IEC 62304, ISO 13485, ISO 14971, and IEC 62366.
Growing complexity and ever shorter release cycles also make it necessary to develop software based on a suitable, agile development process from the request to the release stage. Shorter feedback cycles allow for required changes to be realized quickly in compliance with processes and in a high quality.
With professional Medical Device Software Engineering ...
- you receive software developed in compliance with standards for your medical product
- you have the option to implement changes quickly and in compliance with law
- you have access to the Method Park knowledge of regulations
- you don't have to sacrifice quality
Medical Device Software Engineering Services at Method Park
- Development of medical software in compliance with applicable standards and laws
- Definition of agile development processes in line with standards
- Support in gathering user needs
- Support in performing risk analyses
- Consultation on current topics, such as Medical Device Regulation
- Certified Professional for Medical Software training