Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance

By Becky Blankenship

One of the most challenging aspects of running a life sciences start-up is navigating the waters of the FDA QSR. Remember that your ultimate goal is in line with the FDA QSR - ensuring your medical device safely and effectively meets the needs of patients. The regulations are there to serve as protections rather than act as a stumbling block. However, determining which parts of the QS regulation apply and which don’t can get confusing. We share best practices that will improve your regulatory compliance while producing a product ready for market.