Managing Requirements – A Systems Approach to Medical Device Requirements for efficient and compliant design and development
- Sunrise Labs
- Regulatory Affairs
What are you trying to build? How will you define “success”?
How will the product be used? Do you know how to test the
product? How will the architecture be organized? What do you
need for regulatory clearance or approval?
In this whitepaper, we examine an approach to developing requirements in a manner that provides the critical framework needed to develop your product
without overburdening the effort with endless paperwork and testing. Well executed requirements and requirements-driven development are critical to satisfying customer needs and regulatory constraints, and delivering a quality product on time and within budget.
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