Cali_Kitson
Starting to get Involved
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
Hey all, looking for some opinions on a point of contention.
Our software's intended use is for telecommunication between HCP and patients. However it also allows images from our camera device to be viewed and captured. Our hardware can be used with any old tablet, laptop or computer, however it is supplied with an accessory - a docking case integrated with a tablet, which is loaded with our software.
As the software does not "specifically" enable the device to be used, are we safe to say it is not an accessory?
Please fire away with your opinions.
Hey all, looking for some opinions on a point of contention.
Our software's intended use is for telecommunication between HCP and patients. However it also allows images from our camera device to be viewed and captured. Our hardware can be used with any old tablet, laptop or computer, however it is supplied with an accessory - a docking case integrated with a tablet, which is loaded with our software.
As the software does not "specifically" enable the device to be used, are we safe to say it is not an accessory?
Please fire away with your opinions.