Getting To Know Changes of ISO 14971:2019 (Risk Management for Medical Devices)
ISO 14971 is an ISO standard for the application of risk management to medical devices and it was recently revised in 2019.
This standard establishes the requirements for risk management in determining the safety of a medical device by the manufacturer during the product’s life cycle. This standard is an important link to ISO 13485, establishing a framework for risk analysis, evaluation, control, and review. It also specifies a procedure for the review and monitoring of the device during production and post-production phases. Join this webinar as we explore the specific changes found in the latest ISO 14971:2019 from the 2007 version.
This webinar will provide you with a working knowledge of the update, and introduce users to ISO/TR 24971:2019 as a guidance document for ISO 14971:2019. Finally, this webinar will help you determine the changes (if any) that might be necessary within your organization’s Risk Management System.