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Unlock expert guidance on medical device design and development with Arterex Medicalu2019s comprehensive overview. Learn how to navigate regulatory compliance across major marketsu2014U.S. (FDA 21 CFR Part 820), EU (MDR 2017/745), and global ISO frameworks like ISO 13485 and ISO 14971. Discover essential practices including risk management, usability engineering (IEC 62366), and clinical evaluationu2014designed to ensure safety, efficacy, and traceability throughout the product lifecycle.<br>
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