Standard IEC 62304 - Medical Device Software - Software Lifecycle Processes

IEC 62304, if accepted, requires what reputable medical device manufacturers are already doing. The author therefore expect them to welcome it. It would remove the obligation to describe their processes in detail in regulatory submissions to the FDA. With all its limitations, the author commends IEC 62304. There are still medical device manufacturers whose software development processes are quite rudimentary, and this threatens the lives of patients. IEC 62304 will prevent this and provide a more level playing field for all medical device manufacturers. There appears to be no appetite among either medical device manufacturers or regulators for a more extensive standard prescribing methods and techniques. Holding out for more at this stage would ensure that we get nothing. IEC 62304 also takes a big step towards simpler and more uniform expectations on both sides of the Atlantic