A critical evaluation of a methodology for the generation of software process improvement roadmaps

For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify “what” must be achieved without specifying “how” this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medi-cal device manufacturers. In this work we present a concept for a Software Pro-cess Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap from a set of requirements such as the aforementioned standards and guidance documents.