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Tag Archives: IEC 62304
Full Cycle Teams in a FDA regulated setting
The 200X hot topic was Agile development in a FDA regulated setting. Over a decade later this should (hopefully) be a settled issue. I can’t imagine anyone still doing water-fall these days. The new challenge for medical device companies is … Continue reading
ISO 62304: The Harmonized Standard for Medical Device Software Development
The FDA approved ISO 62304 as a recognized software development standard in 2009. Developing Medical Device Software to ISO 62304 gives a nice overview. Besides providing a globally accepted development process one of the other practical components is the assignment … Continue reading
