Category Archives: Quality Assurance

FDA has released the long-awaited proposed final rule for implementation of the unique device identification (UDI) regulation passed by Congress in 2007.  The initial 60-day comment period began on July 10, 2012.  FDA has extended the comment period until October 25, 2012.  Quoted from the Federal Register, Volume 77, Issue 180, “The Agency has receivedContinue Reading

Many individuals new to the medical device industry in the United States may be confused when they hear the acronym QSR.  The Food and Drug Administration (FDA) Quality System Regulation (QSR) is based on the Federal Food, Drug and Cosmetic Act, otherwise known as The Act in our industry.  The Act is contained in theContinue Reading

Next month at the MEDevice Forum in San Diego, Calif., I will be presenting during the session titled “Examining the Process.” Validation is one of the most confusing and misunderstood compliance requirements. Device manufacturers commonly ask when validation should be performed, what processes require validation, and how much validation is needed. To add to theContinue Reading