Medical Device Product Registration, Product Family, Device Name
Hello,
My company sells medical devices through distributors in the EU, Japan and a few other countries. I want to ask for your advices and view of our problem. Our current product naming stucture is the following for ECG Holter devices without BP: Company name then XX-2H, XX-3H, XX-12H (the xx part is the same always, the letter 'x' is just an example). We have 2 versions from these, one with a display and one without. So we have overal 6 devices from 3 basic type. The hardware is the same, only the software is different.
Registrating all the 6 type would cost a lot in Japan - as every product has a unique name, so only the most populars are registrated from our portfolio (we have several kind of devices), and we are now registrating a new one (one from the above mentioned), which is an updated one (both hardware and box) of an old registrated one with additional features. Yeah, sorry for this, but that seemed to the most cost effiency solution.
I'm a relatively new employ and it's getting more and more confusing as I'm given the task to assembly the DMR and other neccessary documents.
So I'm asking your opinios and advices that what solution would be the most easy and comfortable to our problem.
p.s. we've just had EMC tests and we had to give different names to the LCD and to the LED version, but the basic type that we sell are not the same everywhere, so coutry prefer LED version, e.g. Japan, but others the LCD one, and it would be a lot easier to sell them under the same name and have the same documentation for them.
p.s. 2. I'm hoping that my desription was clear enough, if not, I'm apologizing as it is a little bit confusing for me aswell, as my knowledge is limited to these regulations as I'm an engineer.
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