Good Morning All
About a year ago I took over as the Quality lead for a company making x-ray emitting medical devices. I have recently reviewed our GMDN account and technical file and found what I believe to be a potential discrepancy.
Without giving specifics (and getting in trouble for quoting the full details of the GMDN codes) there are two GMDN numbers that only differ by the final sentence "the main body of the unit is mounted on wheels" or "the main body of the unit is fixed" all other text for the code is identical. The rest of this is a number of sentences describing the device and its function/
Our technical file states that all of our systems fall under the second "the main body of the unit is fixed" GMDN number, however, one of our systems could be argued to have "the main body of the unit mounted on wheels".
What should I do and how would this impact country registrations where we have stated a GMDN number for the system that could potentially be incorrect?
I'm fairly new to the regulatory side of stuff and would appreciate some advice, thanks. Please let me know if I've not been clear or you would like any clarification.
About a year ago I took over as the Quality lead for a company making x-ray emitting medical devices. I have recently reviewed our GMDN account and technical file and found what I believe to be a potential discrepancy.
Without giving specifics (and getting in trouble for quoting the full details of the GMDN codes) there are two GMDN numbers that only differ by the final sentence "the main body of the unit is mounted on wheels" or "the main body of the unit is fixed" all other text for the code is identical. The rest of this is a number of sentences describing the device and its function/
Our technical file states that all of our systems fall under the second "the main body of the unit is fixed" GMDN number, however, one of our systems could be argued to have "the main body of the unit mounted on wheels".
What should I do and how would this impact country registrations where we have stated a GMDN number for the system that could potentially be incorrect?
I'm fairly new to the regulatory side of stuff and would appreciate some advice, thanks. Please let me know if I've not been clear or you would like any clarification.