Product Documentation. Chapter 5. Required Medical Device Documentation. Business proposal Product specification Design specification Software Quality Assurance Plan Software Requirements Specification Software Design Description. Primary types of records. Design History File (DHF)
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Identifies potential territories to be served
Examine market size and trends
Compare product with competitorsMarket Need/ Potential
Where do the pieces fit?
• Balance of business, technical, and other specialists. • External mentors. • Diversity reflecting the institution’s population.
Product specification helps turn this into reality