Hi
I'm setting up a new QMS for low risk custom made class 1 devices (with a Health Institution Exemption) and struggling with how to reflect processes where we have products that are iteratively designed and produced, or purposefully reworked. This could be because:
1: The specifier (a rehab engineer) needs to test the product at numerous points during manufacture to check it will work for the patient. The Rehab Engineer will be much better placed to understand characteristics necessary for successful manufacture better than the technician who is building it. Such characteristics cannot be easily documented on a prescription (specification form).
or
2: The patient is rapidly deteriorating; for example they have Motor Neurone Disease, so the requirements of the custom made communication aid have changed since the patient was first assessed (and the device specified)
Any thoughts?
James
I'm setting up a new QMS for low risk custom made class 1 devices (with a Health Institution Exemption) and struggling with how to reflect processes where we have products that are iteratively designed and produced, or purposefully reworked. This could be because:
1: The specifier (a rehab engineer) needs to test the product at numerous points during manufacture to check it will work for the patient. The Rehab Engineer will be much better placed to understand characteristics necessary for successful manufacture better than the technician who is building it. Such characteristics cannot be easily documented on a prescription (specification form).
or
2: The patient is rapidly deteriorating; for example they have Motor Neurone Disease, so the requirements of the custom made communication aid have changed since the patient was first assessed (and the device specified)
Any thoughts?
James