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Risk Management File Structure Made Easy Plus Checklist

Deep understanding of ISO 14971 requirements for the risk management file (Clause 4.5)
A simple documentation structure for your risk management file
A free check-list to help you compile only the required documentation with step-by-step guidance

Tips and best practices to prepare for an audit of your risk management system

The ability of explanation and the quality of content is amazing! It really helped me to understand the concepts and apply the knowledge.

Vikram T.