Develop an effective Risk Management System across your entire medical device portfolio.
Design & process inputs
- Design input
- Process input
Evaluation of overall residual risk
Production & post-production information
Risk analysis
- Characteristics related to safety
- FMEA Template
- Preliminary Hazards Analysis Example
- Preliminary Hazards Analysis Issue
- Risk Analysis overview
- Risk Estimation document
Risk control
- Benefit-Risk Analysis Individual Risk
- Completeness of Risk Control
- Individual Risk Control Measure
- Residual Risk Evaluation
Risk Evaluation Matrix
Risk Management File
Risk Management Plan
- Criteria for Risk Acceptability
- Overall Policy Risk Acceptability
- Risk Management Plan
Risk Management Review
Risk Management Summary
SOTA literature reviews
Traceability matrix
Quick guide - Risk Management Templates - Edition 1
Choose from our range of professional resources and use your existing product knowledge to build your medical device technical files
Services
Mantra Systems provides professional MDR & IVDR consulting services to companies seeking compliance & market access for any class of medical device.
Resources
Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.
Resources
Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.
If you have any questions about our resources or would like a free & confidential discussion about your medical device, we'd love to hear from you.