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.

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FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors

4.3 ★★★★★ 24 Reviews

ISO 13485 FDA QMSR Medical Devices

FDA QMSR + ISO 13485 Practitioner Training

16hrs

Price: €995.00

FDA QMSR Training is for Practitioners and Auditors who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (Revised Part 820).

FDA QMSR Medical Devices

FDA QMSR Transition

7hrs

FDA QMSR Transition Training is for those with an existing understand of the QSR and ISO 13485 who want to understand the key changes and new requirements introduced by the Quality Management System Regulation (QMSR).

CAPA Practitioner for Medical Devices Training

4.5 ★★★★★ 89 Reviews

ISO 13485 FDA QMSR CAPA Medical Devices

CAPA Practitioner

14hrs

Price: €1095.00

CAPA Training for Medical Devices covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

4.4 ★★★★★ 10 Reviews

FDA QMSR FDA QSR 21 CFR 820 Medical Devices

FDA QMSR Essentials

1.5hrs

Price: €195.00

FDA QMSR Essentials Training is for individuals or organizations looking for a concise, high-level introduction to the FDA’s Quality Management System Regulation (QMSR).

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