Documenting Software for FDA Submissions 2017

  • 1295.00 Dollar US$
  • Published date: June 15, 2017
    • Washington, DC, Courtyard Arlington Crystal City, United States

Course "Documenting Software for FDA Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

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.
The Agile approach helps companies avoid hearing bad news late in a project, by delivering incrementally, integrating regularly, and leaving room for learning as the user stories are refined. In addition, it provides real information on progress and project speed to stakeholders outside the development group.
Documentation under Agile, then, can take advantage of iterative development. Each objection to Agile reveals another point of discipline for effective Agile teams. Requirements can be captured as they are elaborated, and test cases can be firmed up as they are generated during development. For these pieces to fit together, quality processes need to be flexible.
Even clearer is the case for hazard analysis - it and Agile are made for each other. Just as requirements are refined in the course of a project, so too does the knowledge of hazards and design of their mitigations. Risk management, therefore, can and should be included in iteration tasks.
We are coming to see that Agile methods not only result in acceptable medical device development, but lead to much better outcomes. IEC 62304 does not specify any lifecycle model (and states as much); documentation can therefore grow out of iterative activities


Location: Washington, DC Date: August 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA

Price:

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Price: $1,295.00 (Seminar Fee for One Delegate)
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