Kuldeep Singh
Involved In Discussions
As we manufacture the Class IIb medical devices.
We define Storage and transport condition like 0-40 degree and relative humidity upto 90% RH. Our NB raised a question about verification of define temp and Humidity along with vibration parameters. Although we prepare a road transport verification report.Then they raise a question about verification of Sea and Air transport.
So it is not practically possible to verify via Sea or Air during design stage. How can we resolve this.
Thanks in advance for your valuable feedback.
We define Storage and transport condition like 0-40 degree and relative humidity upto 90% RH. Our NB raised a question about verification of define temp and Humidity along with vibration parameters. Although we prepare a road transport verification report.Then they raise a question about verification of Sea and Air transport.
So it is not practically possible to verify via Sea or Air during design stage. How can we resolve this.
Thanks in advance for your valuable feedback.