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Complying with Software Regulations in the Medical Device Industry

Do software developers in your organization like to do peer code reviews? If the answer is “no,” you probably know why. Most peer code reviews take place either around a conference table piled high with stacks of paper or through countless email exchanges. The barriers to effective collaboration are numerous: comments are hard to track in Microsoft Word, conversation threads get mixed up, code changes get lost, it’s hard to involve remote team members, developers take feedback personally—and so on.

Unless specifically exempted in a classification regulation, any medical device software product developed after June 1, 1997, regardless of its device class, is subject to applicable design control provisions.

Download this white paper to understand:
  • Six reasons teams resist peer code reviews
  • Seven essentials of collaborative review
  • Why tool-assisted Peer Code and Document Review makes collaboration easier