Notified Bodies raise concern on Risk Grading
🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does
🩺 Risk Management mistakes that could cost you your certification!
In this episode of the Medical Device Made Easy Podcast, Monir El Azzouzi tackles one of the most common and preventable Notified Body non-conformities: flawed risk grading strategies.
If your team is still using overcomplicated matrices or adjusting severity post-mitigation — this episode is your wake-up call.
🎯 What you’ll learn:
- The most frequent audit findings related to risk grading
- Real-world case studies showing where manufacturers got it wrong
- A clear step-by-step guide to build a compliant and logical matrix
- How to use ISO 14971 & ISO/TR 24971 correctly
- Why severity should NEVER be downgraded after controls
🔧 We’ll also cover:
- How to scale your matrix by device class
- Common pitfalls to avoid
- How to align QA, RA, clinical, and engineering teams
- How Easy Medical Device can help you fix or build your Risk Management system
✅ Whether you’re in Regulatory Affairs, Quality Assurance, R&D, or Clinical, this episode will give you concrete tools to strengthen your risk files and pass your audits with confidence.
📌 Watch now and share it with your team!
📞 Need help? Contact Easy Medical Device to review or improve your Risk Management File.
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
