FDA QSR 21 CFR 820 - Comply Guru Ireland

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FDA QMSR + ISO 13485 Practitioner Training

4.3 ★★★★★ 24 Reviews

FDA QMSR FDA QSR 21 CFR 820 ISO 13485 Medical Devices

FDA QMSR Requirements Training

16hrs

Price: €795.00

FDA QMSR Requirements Training is for those who want 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 FDA QSR 21 CFR 820 Medical Devices

FDA QMSR Transition Training

8hrs

Price: €595.00

FDA QMSR Transition Training is for those with an existing, strong understanding of both QSR 21 CFR 820 and ISO 13485 who want a shorter course covering the key changes and new requirements introduced by the Quality Management System Regulation (QMSR).

FDA QMSR FDA QSR 21 CFR 820 MDSAP Medical Devices

U.S FDA Regulatory Requirements for Medical Devices

120mins

This course provides an overview of the United States FDA Regulatory Requirements for Medical Devices.

4.5 ★★★★★ 11 Reviews

FDA QMSR FDA QSR 21 CFR 820 Medical Devices

Introduction to FDA QMSR

45mins

Price: €95.00

Introduction to FDA QMSR 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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2026 Training Guide

Transformational Training for ISO Standards, Auditing & Medtech QA/RA

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

Low Risk Does Not Mean No Risk

Michelle discusses why ISO 13485 and ISO 14971 make a critical clarification on Risk, and clarifies a dangerous misconception in medical device develo...

MDCG Manual on Borderline and Classification (Version 4)

Borderline products remain one of the trickiest challenges under the EU Medical Device Regulation (EU) MDR 2017/745 and the In Vitro Diagnostic Regula...

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...