Instructor
John E Lincoln
Expectations for meaningful hazard analysis, hazardous conditions, use errors and corrections, design conterol of new and changed product, and documentation have always existed by regulatory agencies.
There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is always a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company, more so now with newer AI-enables devices. How AI can be employed to assist in device risk management will also be considered. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of t design control, and risk management prevention tools. Effective use of such tools, AI-enhances where possible, can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues.
The U.S. FDA has stated that the use of a medical product entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time. This is definately true of AI enabled devices. The best means of risk and use error reduction or elimination is in the device or container design.
This webinar will examing US FDA and EU et al requirements that affect these activities, includiong the 21 CFR's, ISO 13485 7.3, and ISO 14971. Accepted methodologies by which to perform and document such an analysis will be shown. This semiinar will also address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 models to perform and document such activities for any medical productHavomg AI, and considerations for using AI in performing such assessments. It will examine the additional actions necessary to make these useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training toosl, and how to maintain them as a “living document”.
