Using The URA™ to Manage Medical Device Usage Risk
The Medical Device 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 Medical Device 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 Device Design Specifications and Medical Device Usage Instructions must be optimized to define a medical device that does not exceed a failure rate that is acceptable to the customer and the company who designed the product. Also referred to as an “Application FMEA”, the URA™ (Usage Risk Assessment) and its supporting Usage Verification Plan provide a systematic method for accomplishing this task. Using a medical device of the classes choice, attendees will learn how to use the URA™ and Usage Verification Plan to “risk optimize” the Medical Device Design Specifications and Usage Instructions.
The Key role that the URA™ and Usage Verification Plan play 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 Usage Risk Assessment and Usage Verification Plan to “risk optimize” the Medical Design Specifications and Medical Device Usage Instructions.
If material is presented using a multi-day Workshop, the goal is to provide URA™ and Usage Verification Plan 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 product designs and Product Usage Instructions should attend the class.
Students must have knowledge of the product design and use of the product that they choose to use for the class exercises. If they exist, the Design FMEA and Product Usage Instructions for the product that the URA™ will be developed for should be brought to the session.
Class (One Day); Workshop (Two to three Days depending on product complexity).
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I have been working with Harpco Systems for 20 yrs and have seen how their products and services continue to improve to meet customer demands. Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.
Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrastructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
We were very fortunate to work with Rich Harpster and his team as we improved our DFMEA process at Calsonic. There is no better teacher, coach, implementer than Rich when it comes to creating a knowledge base for engineers to use in creating part specs to assure that products meet the customer's requirements.
"I would like to thank Harpco Systems for the help, advice and frankly the education in how to design, develop, source and manufacture new to world products. Not only was the Harpco Systems process scrupulously meticulous in making us evaluate, question, define and then justify every single aspect of our product design, project risks and manufacture process, it was done at a pace that saved us months by not following our conventional processes. By cutting out all the waste and focusing our resources on what was truly important Harpco Systems enabled us to get to a state of production readiness months ahead of our projected schedule. This combined with the incredibly detailed, well documented and most importantly correctly linked/associated technical and risk file information prepared us with a watertight project file with no liabilities missed. Harpco Systems has changed the way myself and others approach product design and development for the better."