ISO 14971:2019 Risk Management for Medical Devices Overview

by Michael B. Checketts published on May 22, 2020

Omnex ISO 14971:2019 risk management overview for medical devices webinar is considered an executive summary of what Risk Management entails for your top management. We go through each clause and take a bird’s eye view of what the expectation is for each clause (approximately 2-3 slides per clause). Finally an overview of their value and importance to the development of risk management for medical device manufacturers.

ISO 14971 Application of Risk Management Standard to Medical Devices establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle, and such activity is required by higher-level regulation and other quality management system standards such as ISO 13485. ISO 14971 is a nine-part standard that first establishes a framework for risk analysis, evaluation, control, review, and also specifies a procedure for review and monitoring during production and post-production.

Omnex offers training and competency development, and implementation and coaching program for ISO 14971:2019 for Medical Devices that include: ISO 14971 Application of Risk Management to Medical Devices OverviewUnderstanding ISO 14971:2019 Application of Risk Management to Medical DevicesISO 14971 Application of Risk Management to Medical Devices DFMEA OverviewISO 14971 Application of Risk Management to Medical Devices PFMEA Overview, and ISO 14971:2019 Application of Risk Management to Medical Devices Including DFMEA and PFMEA.

View this Omnex Webinar to learn more about ISO 14971:2019 Risk Management Requirements for Medical Devices.