TY - GEN
T1 - Medical device software development - A perspective from a lean manufacturing plant
AU - Cawley, Oisín
AU - Richardson, Ita
AU - Wang, Xiaofeng
PY - 2011
Y1 - 2011
N2 - Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.
AB - Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.
KW - Lean Software Development
KW - Medical Device
KW - Process Improvement
KW - Regulated Environment
KW - Software Development Process
UR - http://www.scopus.com/inward/record.url?scp=79959432321&partnerID=8YFLogxK
U2 - 10.1007/978-3-642-21233-8_8
DO - 10.1007/978-3-642-21233-8_8
M3 - Conference contribution
AN - SCOPUS:79959432321
SN - 9783642212321
T3 - Communications in Computer and Information Science
SP - 84
EP - 96
BT - Software Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings
PB - Springer Verlag
ER -
