S
SD1985
Hi,
For a cloud-based stand alone software medical device (Class II), I was wondering how one would have DHR (Device History Records) as each user will have a user name and password to log on the same version of software which is hosted on the cloud. Each user would not get a CD or other physical device. Also, aside from deployment to the cloud, there would be no installation records...Any comments would be very helpful.
For a cloud-based stand alone software medical device (Class II), I was wondering how one would have DHR (Device History Records) as each user will have a user name and password to log on the same version of software which is hosted on the cloud. Each user would not get a CD or other physical device. Also, aside from deployment to the cloud, there would be no installation records...Any comments would be very helpful.