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

Comply Guru are the first in the world to offer Multi-Accredited FDA QSR and QMSR Training with the Chartered Quality Institute (CQI), International Registrar of Certificated Auditors (IRCA) and the Regulatory Affairs Professionals Society (RAPS) offering credentials for the Medical Device Industry that are globally recognized.

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 types of FDA QMSR training courses depending on the target audience and training needs. We can also tailor training to meet your company’s specific needs or requirements. Our courses are available in multiple formats from eLearning, Blended Learning or Instructor-led Learning to help you or your organization master the U.S. FDA Regulations.