Individual Development of Medical Device Software

The bioinformatics department is specialized in the development, validation and certification of application software in the laboratory area and in the field of medical devices. The software applications are designed for highly diverse areas, ranging from the statistical analysis of macroarray data to the fully automated administration of patient samples. Simplification of procedures and supporting the user in his daily work is the main goal of our software.

Requirements Engineering and Software Project Management

All too often the design of a software system and its capacity does not become clear for the involved parties until the end of a project. The resulting deficit in money, effort and time could have easily been avoided through a careful analysis of the requirements. Most project leaders know about this, but still the basics of software-engineering are implemented inadequately, which is not due to the lack of will of the responsible persons. In fact the special knowledge about practical and effective methods of requirements engineering is not adequately considered in the contents of classical education of computer scientists.

We are working with modern methods of requirements engineering to provide our customers with the software, which is desired. For that we focus on a close cooperation and communication with our customers using:

  • Interviews, questionnaires, field-observations etc. to obtain the requirements
  • UML, user stories, scenarios etc. to specify the requirements
  • Object-orientated and “natural” methods to verify the requirements
  • Creation of a complete, contradiction-free, consistent, clear and testable Specification Document
  • Preparation of a test-specification, which allows the examination of the software whether it fulfills the requirements after the development stage
  • Training and coaching of the costumers

Validation according to DIN EN ISO 62304

The development of our products is based on the highest quality-standards. We design medical device software corresponding to DIN EN ISO 62304. Therefore we use a wide portfolio of “Best Practice” in our quality management system. We set a high value on using the newest technologies in the development of software as well as the continuous training of our employees.

Demands of FDA 21 CFR Part 11

The rule “21 CFR Part 11” concerns every software, that is Q-relevant according to the FDA and contains in the broadest sense a process with regard to a signature that was initially made on paper and then replaced by an electronic signature. Depending on the compliance of the particular software build to the FDA guidelines, the additional work for software development lies between 10 – 100 %, according to 21 CFR Part 11.

Because of our experience and continuing education, we know about the demands and “stumbling blocks” connected to a “Part 11” conform software development. Of course these experiences are incorporated in our developments so that our customers receive not only a temporal benefit but also a financial advantage.