Matthew.Le92
Registered
Dear all,
My company is developing a machine that is used to test the Sanofi Insulin Pen function to know if the pen works or not.
The mechanism of our machine is to use the torque sensor to test the dial knob of the insulin pen.
Our product has a similar mechanism as the tester from Zwick Roell as the Youtube link attached:
I have a question that if our machine is determined as a Medical Device or not, since it only tests the function of the Insulin Pen but not to impact directly to human?
I am looking forward to seeing you reply.
Sincerely yours,
Matthew
My company is developing a machine that is used to test the Sanofi Insulin Pen function to know if the pen works or not.
The mechanism of our machine is to use the torque sensor to test the dial knob of the insulin pen.
Our product has a similar mechanism as the tester from Zwick Roell as the Youtube link attached:
I have a question that if our machine is determined as a Medical Device or not, since it only tests the function of the Insulin Pen but not to impact directly to human?
I am looking forward to seeing you reply.
Sincerely yours,
Matthew