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White Paper

Discover Why Traceability Doesn't Have to Be So Hard

Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.
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    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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