good requirements don't stifle innovation - they unlock it by turning vague needs into clear, verifiable design targets
Paper

From Asking Forgiveness to Saying "You're Welcome" - Introducing Requirements Engineering to Medical Device Development

October 29, 2015

Casey Medina

Studio SE, Ltd.

Kristina Carroll

Studio SE, Ltd.

This paper describes a structured, requirements engineering process for individuals, corporate cultures, and industries that are not familiar with requirements engineering best practices. This process was implemented by the authors in the product development process of a medical device manufacturer. This paper presents an example of the implementation of the requirements engineering process using a sample project.

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