Risk Management
360 risk management brings 360 compliance and 360 quality product
Effective risk management creates fundamentally safer medical devices.
Implementation of ISO 14971 requirements is not only mandatory but also helps you identify and address risks at their source, protecting users and strengthening your regulatory position.
Comprehensive Risk Strategy Development
We help establish solid foundations for risk management:
Custom-tailored risk management plans and risk analysis for your device
Integration with your quality management system
Development of appropriate risk acceptance criteria
Creation of practical risk management procedures
Risk Management throughout the product lifecycle
We ensure continuous risk management throughout your product's lifecycle:
Connection of post-market data to risk management
Periodic review processes to keep documentation current
Integration of customer feedback into reassessments
Preparation of risk management report for regulatory submissions
Our clients and partners
