T
TechnicalGuy
Hi Kelly,
Indeed, you are right and the option of searching within the world wide web is possible and I think for class 1 devices a way to success. Additionally, I have to smile because this would be so lovely and cute, if manufacturers would stick together. But the reality seems not like and it seems more harsh.
I try to make an exhaustive comparison of the device under evaluation - our device - and equivalent devices - the plural is intended because I divided the equivalence into three parts: clinical equivalence, technical equivalence, and even biological equivalence. The reason for this is the data you always have about the device and this fragmentation is really helpful. Of course, I have data on my own device for all three fields. There is almost no data available for equivalent devices. I think this is a really funny topic for medical writers / reagulatory affairs manager / and so on....
It would be great if there was a database we could upload all the confidential information to which only NBs or Health Authorities could access. I.e. we say my device is equivalent to this device.... then they go off and judge for themselves! Would make the process so much easier. Only problem is....hackers!