FDA Regulatory Training on the U.S. FDA Quality Regulations (QSR + QMSR)
Comply Guru offer FDA QMSR (and QSR) training that offers the most convenient, flexible, and effective way to learn about the U.S. FDA Quality Management System Regulation & its relationship with 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 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.
WHAT'S NEW
2025 Training Guide
Innovation Leaders for ISO Standards, Auditing & Medtech QA/RA Training
Michelle Keane discusses CAPA in Medical Devices including potential reasons organizations struggle and the FDA raise so many findings in this area....
As per ISO 13485, is it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain...
Comply Guru proudly sponsored Global Access 2024 which is 's largest conference for Quality and Regulatory Affairs Professionals in Medical Devices....
COMPLIANCE SOLUTIONS
Ready to choose Comply Guru and reach the next level?
Global
Ireland
Finland
United Kingdom
United States