-
ljw3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 7 months ago
I think the DHF mindset of continuously documenting the “whole story” is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the entire development process and rationale for key decisions (which is done in the DHF) is advantageous when issues arise in the manufacturing of the device, for example. Its easier to identify the solution to a problem when you know the entire design history and limitations of the product. Its useful to know what controls are in place to manufacture a quality product and what happens when each individual control is not in place (e.g. if a raw material specification is slightly off, how does this affect the quality of the device?).