P
Hi All,
We are developing a thermography device for the early detection of breast cancer. We also provide the user a "diagnosis suggestion" by using our proprietery algorithms to analyze the thermogram.
A thermpograph is classified as a class 1 device according to the meddev. And a similar device on the market has also marked itself as class 1.
However consultants say we are class 2a and should go under examination according to annex 2.
I somehow feel there must be an easier way, at least somewhere in the middle....
Any ideas?
Thanks,
p
We are developing a thermography device for the early detection of breast cancer. We also provide the user a "diagnosis suggestion" by using our proprietery algorithms to analyze the thermogram.
A thermpograph is classified as a class 1 device according to the meddev. And a similar device on the market has also marked itself as class 1.
However consultants say we are class 2a and should go under examination according to annex 2.
I somehow feel there must be an easier way, at least somewhere in the middle....
Any ideas?
Thanks,
p
