W
WP_Regulatory
Hi: I have two questions concerning medical device software:
1) The product in question is software, which is provided with a cart and monitor. The software itself allows clinicians to provide patient care by transmitting patient images from remote locations through the use of telecommunication lines and wireless communication infrastructure. The aspect of the device that makes it Class II is the software; therefore, is it appropriate to consider the software the device, and the other pieces of equipment accessories?
2) What kind of label should be included with the software to meet US label requirements? My thought is that this information should be on the initial splash screen, but I am struggling with whether the monitor and cart, etc., should also include a label specific to US label requirements.
Thanks in advance for any help!
1) The product in question is software, which is provided with a cart and monitor. The software itself allows clinicians to provide patient care by transmitting patient images from remote locations through the use of telecommunication lines and wireless communication infrastructure. The aspect of the device that makes it Class II is the software; therefore, is it appropriate to consider the software the device, and the other pieces of equipment accessories?
2) What kind of label should be included with the software to meet US label requirements? My thought is that this information should be on the initial splash screen, but I am struggling with whether the monitor and cart, etc., should also include a label specific to US label requirements.
Thanks in advance for any help!