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When building your Quality Management System (QMS) for your Medical Device Company, use this simple guide to develop the foundational three-legged-stool.  Realize that building an ideal QMS takes more than a good quality manual.  We must consider people, processes, and tools as critical components of a system that comes together in harmony.

I have been calling directly into the Life Sciences (LS) space for about a year and a half.  I will not call myself an expert, but given that I have been in the business world for over 30 years, I feel I have crossed over into the category of a “gray hair” and therefore I can have some relevant observations.  My below observations are in some ways provided as an outsider looking into the LS industry.