INSTRUCTOR-LED ONLINE COURSE on “ISO 14971 – RISK MANAGEMENT”

Description and content:

1. Description: Comprehensive course on ISO 14971. You will acquire all necessary skill to create, develop and maintain a Risk Management File for medical devices.
2. Content:
   1. Medical Devices and Risk Management;
   2. Overview of ISO 14971;
   3. The building blocks: risk, safety, hazard, harm, failure and cause;
   4. Scoring: probability and severity: the common framework;
   5. Risk analysis techniques;
   6. Examples and workshop;

Who should attend:

1. QAs, engineers, developers and managers wishing to learn about the risk management process for medical devices.
2. Young graduates who want to acquire key knowledge for interviews with Medical Device companies;

MINIMUM 5 PARTICIPANTS (150€ / PERSON)