Risk Management Applied to Medical Devices
(NF EN ISO 14971) (Directives 93/42/EEC and 90/385/EEC)

Consistency with the Technical File; Content of the EC Declaration of Conformity

Course Objectives

This program is designed to provide participants with a variety of knowledge and skills:

• Understand the methodology of risk management for medical devices according to standard EN ISO14971
• Understand the terms and vocabulary in order to document the process and demonstrate that the implemented method meets the requirements of standard
• Identify tools that can be used under this approach
• Understand all the elements needed for the technical documentation to address the requirements of directives 93/421/CEE and 90/385/CEE

Learn More

To get a detailed curriculum, find out scheduled locations or request this program in your area, contact LNE/G-MED America.

For an economical way to train multiple staff, ask us about an on-site program at your company.