Online 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 in the United States 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.
CQI-IRCA Cretified Course Exemplar Global Cretified Course RAPS Cretified Course

WHAT'S NEW

2025 Training Guide

Innovation Leaders for ISO Standards, Auditing & Medtech QA/RA Training

2025 Training Guide

Read, Watch & Discover More

Our team has you covered with expert insights & updates to stay on top of the latest updates, trends, and changes in the industry.

Comply Guru Gains RAPS Approved Provider Status
Comply Guru is now an Approved Provider with the Regulatory Affairs Professionals Society (RAPS) offering more recognition for our Medical Device Trai...
New Courses to Reach New Heights in 2025
Eoin discusses the exciting new courses Comply Guru has launched in 2025 for QARA Professionals within MedTech....
Comply Guru Sponsors Global Access 2024
Comply Guru proudly sponsored Global Access 2024 which is Ireland's largest conference for Quality and Regulatory Affairs Professionals in Medical Dev...

COMPLIANCE SOLUTIONS

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Globally Recognized Qualifications
Training credentials that you can trust.
CQI-IRCA Cretified Course
Exemplar Global Cretified Course
RAPS Cretified Course