Since its foundation, softgate has been developing software for medical devices. The complex and safety-critical processes in the medical field require the highest degree of software liability and software functionality.
Safety Software for Medical Technology: Quality Management in Accordance with EN ISO 13485:2010 and Software Lifecycle in Accordance with EN 62304:2009
In order to ensure this, softgate’s software development for safety related software in medical technology is based on EN 62304:2009. In combination with agile software development, we guarantee the best possible result for your requirements, e.g. when it comes to diagnostics with high-resolution images or moving system components.
Another focus is on the implementation of heavy-duty robot projects in close proximity to the patient during diagnostic or therapy procedures.
Our highly qualified software developers are experienced in embedded software development and will solve any challenge for which there is no standard solution. We will be happy to support you from product idea through product development to the announcement of discontinuation on achievement of your project objectives.
Range of Services in Medical Software Development
Our project teams always develop software according to customer demands in accordance with the currents standards and regulations.
Software Development Process
softgate covers the whole development process:
Product lifecycle management / application lifecycle management, specification, requirement engineering, risk analysis, model based development, architecture, and design, tests on every V model level (code review, unit test, module test, integration system, system test, and acceptance tests).
We pay particular attention to automatable tests. For requirement tracing, we often count on an approach that allows us to link the document type of the respective level of development with other levels as well horizontally as vertically.
Another important aspect in the world of industry 4.0 and the increasingly dense connection of software components of machines previously independent is the issue of security in the meaning of Data Security and Data Integrity. Here, already during software development, softgate performs process-guided development steps, which allow the highest degree of robustness against attacks via external or internal interfaces.
Embedded User Interfaces
You need an attractive user interface for your medical device? We would be happy to realize a professional interface and to integrate it into your product. You can choose between traditional technologies such as QT or HTML5, or popular approaches such as Android (Java) or Blackberry. Of course, we consider every required standard.
From Planning to Turn-Key Software Solution
Last but not least, we offer integration of hardware and software, control systems and communication systems, and development of prototypes up to serial software.