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.
To identify, implement, verify and maintain risk control measures to reduce risk associated with medical devices to an acceptable level.
|Course Title Click on a title to view course description||ID||Duration|
|ISO 14971: 2007 Review||78||35|
|Preparing Risk Management File & Which Techniques Apply||83||24|
|Integrating Risk Management into Your Quality Management System||94||35|
|Implications of EN ISO 14971:2012||N189||28|