ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application
February 15 – 16, 2022
This course is 16 hours. ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s
QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process.
Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive Risk Management processes and explain their interactions with the design and development activities of an organization.