Abstract
In the medical domain, manufacturers are required to implement a Risk Management Process by multiple standards. ISO 14971 provides a framework and taxonomy for medical device risk management process but does not provide details or explanations of its requirements. The IEC 60601 standard family for medical electrical equipment defines the major hazards as an input for the Risk Management Process. Further process standards deal with software and use-related risks in particular (IEC 62304, ISO 62366). It is a challenging task to fulfil all these requirements in one integrated process and provide a comprehensive documentation (Risk Management File) to achieve compliance. We have set up a Risk Management (RM) process for our two different active medical devices. We will share our implementation which handles the Hardware, Software and Use Risk in an integrated way on the functional level. Further particular software-related RM tasks are handled in the software development life-cycle separately. Additionally, we will present our tool chain, which provides evidence of carrying out RM tasks throughout the whole development life-cycle, including connections to the requirement management and effectiveness verification.
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References
ISO 14971:2007 Medical devices - Application of risk management to medical devices
IEC 60601-1:2005 Medical electrical equipment - Part1: General requirements for basic safety and essential performance
IEC 62304:2006 Medical device software - Software life-cycle processes
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC/TR 80002-1:2009 Medical device software - Part1: Guidance on the application of ISO 14971 to medical device software
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© 2013 Springer-Verlag Berlin Heidelberg
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Tényi, B., Csík, A., Monoki, I., Tegzes, F. (2013). Experience with an Integrated Risk Management Process in the Medical Regulatory Environment. In: McCaffery, F., O’Connor, R.V., Messnarz, R. (eds) Systems, Software and Services Process Improvement. EuroSPI 2013. Communications in Computer and Information Science, vol 364. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-39179-8_31
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DOI: https://doi.org/10.1007/978-3-642-39179-8_31
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-39178-1
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