Course Overview:

This course is designed to provide an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices.  It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard as well as the skills for implementing risk management activities for the medical devices.

Course Outcome:

– Able to define risk management terminology

– Able to explain how risk management relates to the product lifecycle

– Able to outline the stages of the risk management process

– Able to define the key deliverables of the risk management process

– Able to apply risk management principles within your organization

– Able to identify the links between ISO 14971:2019 and ISO 13485:2016

– Able to have better planning and framework of risk management

– Able to demonstrate compliance to regulations

– Able to have structured approach while implementation of ISO 14971

– Able to ensure product development with desired quality and safety standards

– Able to ensure integration of risk management into an existing Quality Management System

Course Outline:

• Framework for Managing Risk
• Using DFMEA for Integrated Risk Management
• Steps of the FMEA Process
• Types of FMEAs
• Establishing a Team
• Developing an FMEA
• Risk Evaluation
• Risk Treatment
• Safety Tactics
• Monitoring and Review
• Summary

NOTE: For other AS9100 related courses including technical training requests kindly contact us directly at 04-441 1524 or email us at admin@kgscert.com