A
antho10359
What are the support requirements, if any, for a Class 2 Medical Device? Is there a prescribed period of time required to support a medical device that is no longer manufacturered?
I haven't come across a requirement for this. The regulations for records are 2 years or the expected life of the device, whichever is greater. Somewhere you had to have defined the expected life of the device.antho10359 said:What are the support requirements, if any, for a Class 2 Medical Device? Is there a prescribed period of time required to support a medical device that is no longer manufacturered?