Fraunhofer Center for Experimental Software Engineering Announces CRADA with FDA Center

PR Log (Press Release) – Aug 17, 2009 – College Park, Maryland -- The Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories (FDA/CDRH/OSEL) has entered into a Cooperative Research and Development Agreement (CRADA) with Fraunhofer Center for Experimental Software Engineering (CESE) to further research in the area of software engineering. The CRADA is a formal legal instrument under which government and academic research is sanctioned.

For over 30 years, organizations have been trying to develop quality software systems based on the premise that quality development processes deliver quality software. One of the major flaws in this premise is that there is always a difference between (abstract) design specifications and (concrete) human crafted software / code. The saying among experts is that the code represents the final specifications.

From a forensic perspective, design documentation is of limited use when a medical device fails due to a software error. A forensic investigator must work with the code to identify a software error, and then through analysis understand its relationship to the design specifications and system architecture.

The Software Architecture and Embedded Systems (SAES) division at CESE has, together with its sister institute Fraunhofer IESE in Kaiserslautern Germany, been exploring this issue for several years resulting in a software tool called SAVE (Software Architecture Visualization and Evaluation http://fc-md.umd.edu/save/). The tool facilitates reverse-engineering software architecture statically from files containing source code. SAVE does this by performing detailed static analysis to identify the dependencies (imports, method call, inheritance) between code components and then uses component definitions supplied by the user to construct the software architecture. This architecture may then be visualized by defining different levels of abstraction, with the tool creating automatic links between the different abstraction levels to allow a user to navigate from high-level component-level views down to the code-level. SAVE can be used for code comprehension and to detect deviations between the extracted architecture and the "ideal" architecture, where the "ideal" is defined to be what the architecture ought to be.

According to Rance Cleaveland, PhD, Executive and Scientific Director of the Fraunhofer Center for Experimental Software Engineering, "This Cooperative Research and Development Agreement with the Food and Drug Administration offers a tremendous opportunity for synergistic research into improved safety for medical devices. We appreciate their commitment to us through this arrangement, and we look forward to being a part of the team in this exciting and important endeavor."

Software Architecture and Embedded Systems (SAES) is a division within the Center for Experimental Software Engineering at the University of Maryland in College Park, Maryland.  The non-profit applied research and technology transfer organization is led by CEO Dr. Rance Cleaveland who is also a full Computer Science professor at University of Maryland College Park. Further information is available through http://fc-md.umd.edu or by calling Dr. Arnab Ray, Scientist, at 240.487.2914.