FDA QMSR: QSR, ISO 13485 & Harmonization Explained
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FDA QMSR: QSR, ISO 13485 & Harmonization Explained
Explaining the QMSR (quality management system regulation) Final Rule by FDA to harmonize its quality system regulation (QSR) with ISO 13485:2016.
Aug 15, 2024
FDA QSR Compliance
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ISO 13485 Certification Not Enough for FDA QMSR Compliance | AMORIT EDUCATION posted on the topic | LinkedIn
ISO 13485 Certification Not Enough for FDA QMSR Compliance | AMORIT EDUCATION posted on the topic | LinkedIn
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1.7K views · 15 reactions |  Talking to patients about their generic drugs improves usability, compliance, outcomes, & can save healthcare professional time in the future. Learn more in our “Q&A with FDA” podcast with Dr. Sarah Ibrahim from FDA’s Office of Generic Drugs: https://www.fda.gov/media/182274/download?attachment | U.S. Food and Drug Administration | Facebook
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1.7K views · 15 reactions |  Talking to patients about their generic drugs improves usability, compliance, outcomes, & can save healthcare professional time in the future. Learn more in our “Q&A with FDA” podcast with Dr. Sarah Ibrahim from FDA’s Office of Generic Drugs: https://www.fda.gov/media/182274/download?attachment | U.S. Food and Drug Administration | Facebook
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