Description and content:
- Description: Comprehensive course on ISO 14971. You will acquire all necessary skill to create, develop and maintain a Risk Management File for medical devices.
- Medical Devices and Risk Management;
- Overview of ISO 14971;
- The building blocks: risk, safety, hazard, harm, failure and cause;
- Scoring: probability and severity: the common framework;
- Risk analysis techniques;
- Examples and workshop;
Who should attend:
- QAs, engineers, developers and managers wishing to learn about the risk management process for medical devices.
- Young graduates who want to acquire key knowledge for interviews with Medical Device companies;