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After reading the recently released IOM report on 510(k)s, I started thinking about how FDA can do better. Here are my recommendations on how to fix FDA...
In the 70’s, I worked as a quality manager in a small company that produced packaging component for big medical device companies. One of our product...
In highly segmented organizations, communication is good up and down an organizational silo but poor across organizations. Unfortunately, this type of...
Outsourcing to China is an increasingly popular strategy for medical device manufacturers. But there are a number of risks in doing so. Business ethics can be...