Requirements Debt: A Medical Product Program Risk

Most organizations do not identify requirement clarity and management as a high effort, high impact to the product item, if it is even identified at all. Some organizations believe requirements do not pose a traditional existential threat to the program because the cost of poorly defined or missed requirements is not immediately measurable. 

However, as you’ll see in this whitepaper, Requirement Debt™ has a major impact on time, scope, and budget. In this paper, we’ll cover:  

  • The impact of requirements debt on medical device development 

  • The value of proactively writing traceable, testable requirements 

  • Mitigating costly, late-stage change with proactive requirements management 

 

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