For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

chapter 1|9 pages

Regulation, business, and Six Sigma

chapter 2|19 pages

Design Control roadmap

chapter 7|2 pages