I have come upon the task of getting a 60601 3rd edition test done on a product that has been used in the field for already 20 years. We acquired the company 10 years ago with the existing product, and do not have access to any of the original design or usabilty studies that were done when the project was started.
We are currently ISO 13485 and ISO 9001 certified and have a CE Mark for the product.
How can I successfully address the usability issue that now comes up with the 3rd edition?
Any suggestions would be appreciated.
Also I might mention that there have been No incidents ever reported with this equipment and it has been used by patients all over the world
We are currently ISO 13485 and ISO 9001 certified and have a CE Mark for the product.
How can I successfully address the usability issue that now comes up with the 3rd edition?
Any suggestions would be appreciated.
Also I might mention that there have been No incidents ever reported with this equipment and it has been used by patients all over the world