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Medical Software Quality Regulations have been developed through a concern for patient safety, outcome and care. From our research on a variety of projects, which includes observation within hospitals and clinics, we can demonstrate that there are many situations in which regulations and directives regarding medical device software are not being taken into account, and unregulated software is developed and used in healthcare organisations. This happen mainly because people, not trained in software engineering within a lack of knowledge in regulations develop software solutions for healthcare. In addition, healthcare professionals are unaware of regulations and the effect unregulated software may have on patient and practitioner alike, and so use these systems.Software Engineers have a role to play to solve this problem. We recommend that, healthcare software systems are developed by professional software engineers in interdisciplinary teams with healthcare professionals. Software engineering and healthcare academics can collaborate on the development of modules within healthcare courses and the development of specialist courses. Through these, healthcare professionals will be educated on the value of software engineering practices and principles, and on the requirement for regulation in the development of medical device software. Software engineering courses should include topics focused on Medical Device Software development.

peer-reviewed Software Product Lines (SPL) is a methodology focusing on systematic software reuse, multiple benefits have been reported as a result of this type of software development. However, establishing a SPL is not a simple task. It is a challenging activity raising many challenges for engineering and management. This research aims to manage the risks during SPL development to provide traceability among them. For this, it is important that the risks are documented and there is a common design related to them. As solution, we identified the strengths and weakness in SPL development and the importance in designing of communication for risk documentation.