(Total Views: 374)
Posted On: 11/17/2018 4:29:33 PM
Post# of 32187
Crazy they can offer prescriptions like that. I have to run an ISO 13485 quality system with seriously involved risk management SOP’s amongst others for all of my software. I am surprised it is not considered a device and require a 510K. The scale & scope of the NotifiMed is mind blowing.
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