Risk Management for Medical Devices in the EU and US
Estimated Learning Duration of the Program:
94
Program Description
Program Description:
This suite has 3 courses. Course one is a review of the risk management standard ISO 14971-2007. Course two explains how to prepare a Risk Management File and which techniques apply. Course three shows how to integrate Risk Management into the Quality System.
Learning Objectives:
To identify, implement, verify and maintain risk control measures to reduce risk associated with medical devices to an acceptable level.
Basics in Regulatory Affairs Certificate
| Course Title Click on a title to view course description | ID | Duration |
|---|---|---|
| ISO 14971: 2007 Review | 60 | 35 |
| Preparing Risk Management File & Which Techniques Apply | 61 | 24 |
| Integrating Risk Management into Your Quality Management System | 62 | 35 |
Program Pricing
Prices have not been set for this program.