• Speaker : Edwin Waldbusser
    • Session Code : ERAUG2823
    • Date : 28th August 2023
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 75 Mins


In the field of medical technology, the integration of Machine Learning (ML) within medical devices has introduced new possibilities and additional complexities in risk management. Recognizing this challenge, regulatory authorities, including the FDA, emphasize adherence to standards such as ISO 14971 and the recently issued AAMI/BSI TR 34971, designed to guide risk management for AI and ML applications in medical devices.


This webinar provides a comprehensive insight into the ISO 14971 risk management process and the unique risks posed by ML in both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). Key terms like "hazard," "hazardous situation," "harm," "causative event," "ALARP," and "risk index" are explained, and the session walks through the process of conducting a hazard analysis, aiming to demystify the complexities surrounding ML in medical devices.


Furthermore, the webinar explores critical issues related to ML, such as the Predetermined Change Control Plan (PCCP), data quality, bias, and cybersecurity. With examples of hazards and hazardous situations, attendees will gain practical insights into the application of standards and alignment of ML-driven medical devices with regulatory requirements.


As the industry continues to embrace technological innovations, understanding and navigating the evolving landscape of risk management is paramount. This webinar serves as a resource, shedding light on critical aspects of risk management for ML medical devices and the guidance provided by AAMI/BSI TR 34971 and ISO 14971.


Areas Covered in the Session:

  • Hazard analysis terms and process
  • Quality Control (QC) of datasets
  • ML Algorithm updating
  • Reference standard development
  • Importance of “explainability”
  • Cybersecurity

Why Should You Attend?

The FDA's endorsement of ISO 14971 and the newly issued AAMI/BSI TR 34971 guidance reflects the essential nature of risk management for software as a medical device (SaMD) and software in a medical device (SiMD). With ML introducing added complexities, this webinar offers a step-by-step guide to understanding and applying risk management techniques.

From clear explanations of key terms to discussing the additional hazards and situations attributable to ML, attendees will gain practical insights and examples to effectively navigate the intricate landscape of risk management in this dynamic field.

Who Should Attend?

  • Medical Device Manufacturers
  • Software Developers in Medical Industry
  • Risk Management Professionals
  • Compliance Officers
  • Quality Assurance Teams
  • Regulatory Affairs Professionals
  • IT and Security Professionals

Edwin Waldbusser is a consultant retired from industry after 25 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 13 years.

Mr. Waldbusser has a BS in Mechanical Engineering from NYU and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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Tags: Medical Devices, Machine Learning, Risk Management, ISO Standards, Cybersecurity, Regulatory Compliance, FDA, Edwin, Waldbusser, Webinar, August 2023