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FDA QMSR and ISO 13485: Harmonisation Guide

Summary by Tech Research Online
FDA QMSR and ISO 13485: Harmonisation Guide Prepare Your Life Sciences Organisation for Regulatory Changes The FDA’s harmonisation of 21 CFR Part 820 with ISO 13485 marks a significant shift in medical device quality management. This comprehensive guide offers UK and EU life sciences manufacturers essential insights into the Quality Management System Regulation (QMSR) harmonisation process, its impact on current practices, and strategies…
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Tech Research Online broke the news in on Monday, May 5, 2025.
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