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Risk Management for ML medical devices following AAMI/ BSI TR 34971 and ISO 14971
- Hazard Analysis Terms.
- Hazard Analysis Process.
- QC of Datasets.
- ML Algorithm Updating.
- Reference standard development.
- Importance of “explainability”.
- Cybersecurity.
Overview of the webinar
FDA has always maintained risk management of medical devices as a top priority. FDA has it’s regulations and has also endorsed the use of ISO 14971. Risk management for software as a medical device (SaMD) and software in a medical device (SiMD) is a complex subject and ML adds another level of complexity.
Recently AAMI/BSI TR 34971 was issued: “Guidance on the application of ISO 14971 to AI and ML”. It’s predecessor, AAMI CR 34971, has been endorsed by the FDA.
This webinar will explain the ISO 14971 risk management process and explain the additional risks ML poses.
Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it evaluates risks in normal operation as well as fault conditions.
In this webinar we will explain the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, and “risk index” will be explained. We will go step by step through the risk analysis process so that the process is clear. Examples of hazards and hazardous situations will be presented. The additional hazards and hazardous situations attributable to ML will be discussed. Issues important to ML such as the Predetermined Change Control Plan (PCCP), data quality and bias will be discussed.
Who should attend?
- Software Engineers
- Regulatory Personnel
- Quality Assurance Personnel
- Management
- Senior management in FDA/ NB CGMP regulated industries
- Quality Analysts
- Research Analysts
- Research & Development Engineers
- Engineers
- Production Managers
- Operations Managers
- Marketing Managers
Why should you attend?
FDA has always maintained risk management of medical devices as a top priority. FDA has it’s regulations and has also endorsed the use of ISO 14971. Risk management for software as a medical device (SaMD) and software in a medical device (SiMD) is a complex subject and ML adds another level of complexity.
Recently AAMI/BSI TR 34971 was issued: “Guidance on the application of 14971 to AI and ML”
This webinar will explain the ISO 14971 risk management process and explain the additional risks ML poses.
In this webinar we will explain the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, and “residual risk” will be explained. We will go step by step through the risk analysis process so that the process is clear. Examples of hazards and hazardous situations will be presented. The additional hazards and hazardous situations attributable to ML will be discussed.
Issues important to ML such as the Predetermined Change Control Plan (PCCP), data quality and bias will be discussed.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.