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