Lean Six Sigma for Medical Device Excellence and Regulation

Authors: Sunil A* and Somya A

DOI: 10.23880/apct-16000111

Volume 1, Issue 2

Abstract

Medical device industry is one of the fastest growing industries in US with over $80 billion market. The industry makes medical products ranging from simple glucometers to computer managed surgical gadgets, from implants to artificial organs. There are new products being launched in the market on a daily basis. Lean Six Sigma plays a key role in quality management throughout the medical device product life cycle and helps to achieve desired end results.

Keywords: Medical device; Regulation; FDA, Quality; Lean six Sigma

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