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Understanding Risk Management Requirements in ISO 13485:2016

Understanding Risk Management Requirements in ISO 13485:2016

The current revision of ISO 13485:2016 has new requirements for risk management. Here are some questions to consider and guidance for implementation.

Regulatory ComplianceNaveen AgarwalJanuary 10, 2020ISO 13485:2016, Risk Management, Risk management for medical devices, understanding risk management, quality management system, quality management system for medical devices, risk-based approachComment