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Development of software for safety critical medical devices - an interview-based survey of state of practice

Publiceringsår: 2008
Språk: Engelska
Dokumenttyp: Konferensbidrag


To be able to survive in the long run the medical device industry of today needs effective development processes and ways to secure quality. These development processes and quality assurance processes must follow the different laws and regulations over the world depending on what market the organisations are established on. Organisations have been developing medical devices and systems over many years but now this type of

products contain more and more software. The development of software is often appended in to the existing development and quality assurance processes and these processes may not be the most efficient and correct processes when it comes to software. This paper presents the results from an interview study with the purpose to survey how the medical device companies work today, what development processes and quality assurance techniques they use and how laws and regulations affect their way of working. Safety is very essential for the medical device organisations and all the interviewed organisations consider the software in their medical device as safety critical. Risk and risk analysis is an important part of the safety thinking and is frequently performed by the organisations. However established and systematic techniques to analyse risks of the medical devices

are not so frequently used as expected. The intension is that the results from the study could be used as a

help to find more adapted processes and techniques for software development in the medical device domain. The results have also been used to derive a set of requirements on new techniques and methods in the area. The derived requirements can serve as guidance to researchers aiming at improving processes, methods and techniques in the medical device domain.


  • Computer Science


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