Regulatory issues: what is in the QSR/GMP?

Abstract

Medical device manufacturers must comply with the Quality Systems Regulation (QSR) in order to market products in the United States. Therefore, if one wish to be an entrepreneur in medical devices or even just work in the medical device industry, an understanding of what the QSRs are about is necessary because violations of these regulations can lead to expensive legal entanglements. Although there can be serious consequences to not complying with the regulations, the key thing to remember is that a good quality system is good business - it helps the business to run smoothly by having the appropriate checks and balances to help catch problems early. The text of the QSR is found in Title 21 of the Code of Federal Regulations, Part 820 (21 CFR 820). The current version was published in 1997. Prior to that, 21 CFR 820 was known as the Good Manufacturing Practices (GMP). This article will give a brief overview of what the QSR entails.