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White Paper

Discover Why Traceability Doesn't Have to Be So Hard

Software is the leading cause of medical device recalls.  Heavily regulated products such as safety-critical medical devices require that every step of the development process must be traceable with a rigorous process designed to identify potential risk factors and their contributing conditions. 

  • Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.
  • Overview of the latest best practices and tools for traceability
  • Includes an FDA-approved template and guidance on a more integrated approach to traceability to empower manufacturers to develop better, safer software, faster.
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