Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated medical devices are known as Quality System Regulation (QSR), or device current good manufacturing practices (device CGMP’s). QSR requirements in 21 CFR part 820 were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Today, the QSR applies to finished device manufacturers who intend to commercially distribute medical devices.
The QSR Booklet App presents QSR (device CGMP*) in a user-friendly e-format. The users can easily reach to each section of QSR regulation plus search function. This is a convenient self-education and information tool for all people working in medical device industry.
*Note : Per the most current revision to the date of the app publication