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FDA QMSR Transition Training

8hrs

Price: €695.00

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 Regulatory Requirements for Medical Devices (United States)

MDSAP FDA QMSR FDA QSR 21 CFR 820 Medical Devices

U.S FDA Regulatory Requirements for Medical Devices

120mins

Price: €225.00

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

4.3 ★★★★★ 23 Reviews

FDA QMSR FDA QSR 21 CFR 820 Medical Devices

Introduction to FDA QMSR

45mins

Price: €95.00

Introduction to the 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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Reaffirmed, Not Static: ISO 13485 and the Global Regulatory Evolution

Michelle discusses the recent affirmation of ISO 13485:2016 and shares her insights on the new guidance reflecting a Global Regulatory Evolution....

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...