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When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto.
Date :
Place : United States, Arlington
Contact Person:Paula Edwards
Description:
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto.When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rather than contradict the Agile manifesto. will be held in Arlington,United States on date 2017-08-11
Deadline for abstracts/proposals : 1st August 2017
Organized By :New York Events List
Keynote Speakers : Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufactu
Conference Highlights :Agile vs IEC 62304: an apparent contradiction? The role and value of documentation The REAL regulatory requirements Specific documents required for an FDA submission Areas where most development processes bog down Iteration - well suited for risk, usability, and design reviews Key practices to bridge the Agile and regulated worlds Agile is not only acceptable for medical device software, but can be clearly superior
Venue :Arlington, VA 22202, United States
Check the event website for more details.
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