Mon, Oct 12, 8:30am - Oct 13, 5:30pm Eastern Time (2 sessions)
This course has been designed to help you understand the requirements for understanding, analyzing, and managing medical device risk using ISO 14971:2007. Participants will understand the standard, determine documentation requirements, and develop implementation strategies. The course also describes the issues raised by the European Union version, EN ISO 14971:2012.
Participants will understand the requirements of the risk management process including plan, analysis, evaluation and risk reduction.
Knowledge of medical device regulation
Terms and definitions
General requirements for risk management
Evaluation of overall residual risk acceptability
Risk management report
Production and post-production information
Who Should Attend?
Individuals interested in learning how to develop and deploy risk methodologies including implementing ISO 14971.
This course is available for "remote" learning and will be available to anyone with access to an internet device with a microphone (this includes most models of computers, tablets). Classes will take place with a "Live" instructor at the date/times listed below.
Upon registration, the instructor will send along additional information about how to log-on and participate in the class.
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