ISO 14971 Training | Medical Device Risk Management Explained
Автор: easyQ solutions
Загружено: 2025-03-17
Просмотров: 199
Описание:
In this ISO 14971 training video, we provide a comprehensive guide to ISO 14971:2019, the international standard for risk management in medical devices. Understanding and implementing risk management is crucial for regulatory compliance, patient safety, and product quality. This training covers the key concepts, requirements, and best practices for effectively managing risks throughout the medical device lifecycle.
✅ What You’ll Learn:
✔️ Introduction to ISO 14971 & its significance
✔️ Key principles & terminology in risk management
✔️ Step-by-step risk assessment process
✔️ Hazard identification & risk mitigation strategies
✔️ Integration of risk management into QMS & ISO 13485
✔️ Compliance with global regulations (FDA, EU MDR, etc.)
📢 Who Should Watch?
✔️ Medical device manufacturers
✔️ Quality & regulatory professionals
✔️ Risk management specialists
✔️ Auditors & consultants
✔️ Anyone preparing for ISO 14971 compliance
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