Using The Application FMEA To Manage Medical Device Usage Risk
(Note: Training offered in both class and workshop format)
The Medical Usage Risk Management Process fails any time a Medical Device Design Specification (i.e. dimension, material property and/or software code) is released to manufacturing and/or Medical Usage Instructions are released for customer use that results in a product failing due to the way it is used. When this happens both the company who designed the product and the end customer are exposed to risk. Although no failures due to usage is the goal, the Medical Design Specifications and Medical Device Usage Instructions must be optimized to define a product that does not exceed a failure rate that is acceptable to the customer and the company who designed the medical device. Also referred to as a “Usage Risk Assessment” or “URA®”, the Application FMEA provides a systematic method for accomplishing this task. Using a medical device of the class’s choice, attendees will learn how to use the Application FMEA to “risk optimize” the Medical Device Design Specifications and Usage Instructions.
The key role the Application FMEA plays in meeting the risk-based thinking requirements of ISO 13485:2016 will be explained.
Using a medical device of the classes choice, attendees will learn how to use the Application FMEA to “risk optimize” the Medical Device Design Specifications and Medical Device Usage Instructions.
If material is presented using a multi-day Workshop, the goal is to provide an Application FMEA of “Customer Delivery Quality” as well as educate attendees on the fundamentals of their use and creation.
Who Should Attend
All personnel who are responsible for the creation and maintenance of medical device designs and Medical Device Usage Instructions should attend the class.
Students must have knowledge of the medical device design and use of the medical device that they choose to use for the class exercises. If they exist, the Design FMEA and Medical Usage Instructions for the product that the Application FMEA will be developed for should be brought to the session.
Class (One Day); Workshop (Two to three Days depending on product complexity).