ISO 14971:2019 Application of Risk Management to Medical Devices

Virtual Learning

December 3 – 4, 2020

Course Overview

This fully online 2-day course is a highly interactive training that includes case study exercises, competency assessment, and Certificates of Completions.

This course will provide an understanding of the risk management standard (ISO 14971:2019). By the end of the training, students will be able to:

  1. Evaluate the fundamental requirements from medical device regulation relating to risk management
  2. Discover ISO 14971 step-wise approach to risk identification, assessment, control and evaluation
  3. Develop specific knowledge on how to implement risk management within the Product development, Product Manufacturing and Post Market phases of a product lifecycle
  4. Establish Risk Acceptability criteria
  5. Learn risk management tools and activities from defining product characteristics to the preparation of risk management summaries for regulatory submission.
  6. Discover the tools, techniques, information and records required to develop a successful risk management program and use as a basis for US regulatory reviews
This course includes a 2-hour "ISO 14971 Overview" module that must be completed prior to the start of the live instruction.