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HEALTHCARE

Risk Management

The new ISO 13485:2016 Quality Management System, clause 4.2.1, states: 'The organization shall apply a risk-based approach to the control of the appropriate processes needed for the quality management system.' In other words, anything that affects the quality system must be evaluated from a risk-based perspective.

We can assist medical device manufacturers in a comprehensive and in-depth understanding of ISO 14971 requirements for risk management, including:

General requirements for risk management
Risk analysis
Risk control
Risk/benefit analysis
Risk management report
Production and post-production information
Risk management file