The FDA regulatory pathway for commercializing medical devices can be a maze of mandates which, if disregarded, can slow time to market, inflate design and development costs, and even result in ...
Do you need a design or functional specification? It depends on who your audience is and where you are in the product development cycle. People often confuse the purpose and role of functional ...
People often confuse the purpose and role of functional specifications and design documents. Design and function should never meet in a document. Design and function must be documented during the ...