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Risk Management
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
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