Risk Management Standard for Medical Devices: Implementing NEW ISO 14971:2019

Risk management is an essential component of any Quality Management System, but businesses are struggling to keep up with regulatory updates and the impact on their QMS.

Significant changes in the regulatory environment have shifted to risk-based processes, emphasizing the Risk Management files for medical-related products. ISO 14971:2019 was published to harmonize those concepts across multiple regulatory bodies, as well as to incorporate some significant changes in the existing risk management landscape.

Concerning the transition to ISO 14971:2019, the FDA has stated that it will continue to accept declarations of conformity to the previous version, ISO 14971:2007, in support of premarket submissions until December 25, 2022. "After this transition period, declarations of conformity to [ISO 14971:2007] will no longer be accepted,"

Risk approach has become a mandatory practice during the Product Realization of Medical Devices. This practice should be applied as per ISO14971: 2019, the brand-new revision of the well-known and practice standard.

This webinar is intended for engineers and managers in the medical devices industry who are required in the line of their job to be acquainted with the Risk Management process or those who are familiar with the risk management process and would like to refresh their knowledge. 

In addition, this presentation presents the new ISO14971: 2019 Medical Devices — Application of Risk Management to Medical Devices and compares it to the previous revision of the standard (2007/2012). Also – the presentation presents the new ISO/TR24971: 2020 - Medical devices — Guidance on the Application of ISO 14971.

Mr. Shapiro will present the basic principles and practices of Risk Management and Risk Analysis. The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical device products. 

This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementation in the design and development stages of the medical device. The presentation will include how to implement best practice tools to manage risk analysis and risk management. In addition, the webinar shall present the changes in the new revision of the standard.

• Risk-based Approach
• Risk Management Fundamentals
• Risk Analysis
• FMEA
• ISO14971: 2019 Medical Devices — Application of Risk Management to Medical Devices
• ISO/TR24971: 2020 - Medical devices — Guidance on the Application of ISO 14971

• Medical Device Executives
• Quality Assurance Managers 
• Regulatory Professionals 
• Quality Assurance Engineers
• R&D Engineers and Management
• Production Managers
• Product Engineers, Usability Engineers
• Persons creating and/or updating Design Control processes