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Risk Management File Structure Made Easy Plus Checklist

Build an ISO 14971 compliant risk management file! 

What you'll get:

  • 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

Bonus Offer

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

What People Are Saying:

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.