ISO 13485 & FDA QSR Foundation Training
This course is for anyone who needs to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).
FDA QSR 21 CFR Part 820 Training that offers the most convenient, flexible and effective way to learn about the U.S. FDA Quality System Regulation & ISO 13485.
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 is working to harmonize its regulation with ISO 13485 (2016).
2023
Catalog
This course is for anyone who needs to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (21 CFR Part 820).