ISO 14971 Risk Management Training for Medical Device Companies

ISO 14971:2019 provides a framework for manufacturers and critical suppliers to identify, analyse, evaluate and control risks associated with medical devices throughout their lifecycle. Another important part of risk management under this standard is Benefit-Risk Analysis. Benefit-Risk Analysis of Medical Devices is difficult and interesting. Benefit-Risk analysis is expressly required in MDR Annex I. While producing medical devices, the benefits to the patient are taken into consideration. But in addition to this situation, the class of the medical device, the place of use, the way it is used, the working principle of the device, etc. There are always risks to arise and it is necessary to establish an effective risk management process to keep these risks under control.

This instructor-led two-day course provides the fundamentals of the risk management process in line with the expectations of 2017/745 MDR, EN ISO 14971 and the newly published ISO/TR 24971, providing expert tips on how to move forward in the process.

Exhibitor Profile

Medical device design, development and production etc. It includes the personnel in the management and management staff in the Quality Assurance / Engineering / Production units related to the life cycle.

Prerequisites

You must have experience or basic knowledge of quality management systems within the medical device industry. We strongly recommend that you have a basic knowledge of medical device manufacturing, quality assurance and ISO 13485:2016 processes for the success of the training.

What will I learn?

After completing this training you will be able to:

• Risk management terminology
• How risk management relates to the product lifecycle
• Stages of the risk management process
• Key outputs of the risk management process
• Risk management practices within your organization