FDA Regulatory Training on the U.S. FDA Quality Regulations (QSR + QMSR)

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a document that outlines Current Good Manufacturing Practice (CGMP) regulations and is an important regulation for Manufacturers wishing to place medical devices on the market in the U.S. The FDA has published its final rule where the new Quality Management System Regulation (QMSR) will come into effect in February 2026 and more closely align with ISO 13485.  Comply Guru offer different tiers of training depending on the needs of your group.