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11.1.3 Medical Device Development Process
Author(s) -
Jones David J.,
Masters Melissa T.
Publication year - 2008
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2008.tb00873.x
Subject(s) - process (computing) , scalability , computer science , variety (cybernetics) , risk analysis (engineering) , quality (philosophy) , work in process , medical device , business process , process management , process safety management , engineering management , systems engineering , engineering , software engineering , business , operations management , biomedical engineering , philosophy , epistemology , database , artificial intelligence , operating system , waste management , hazardous waste
Medical devices of increasing complexity are central to mankind's continuously expanding ability to save lives and improve the quality of life. Within our business, we often reflect on how fortunate we are to have the opportunity to work on a variety of these remarkable devices. We believe that such rewarding experiences are made possible through the application of a rigorous system engineering process, ensuring that the resulting devices are safe, effective, and successful. This paper describes a deployed System Engineering process tailored for Medical Device Development. This process (based on ISO 15288:2002, the INCOSE System Engineering Handbook and a Legacy Process), integrates compliance to international regulations, embeds a Safety Risk Management process as defined in ISO 14971:2007, and assures adherence to ISO 13485:2003 Quality management systems. Based on the classification and complexity of the device the process is scalable, may be tailored, and supports iterative design and development activities.