QA RA Small Med Dev Company
Trusted Information Resource
We design, manufacture, and sell a 510K Class II device and we recently introduced a clinical application for the device to used in hospitals. Our device takes and transmits a biometric data point to be processed and stored in the cloud and accessible by nurses and later manually entered into the EHR of each patient. Does our device and supporting data structure need to conform to 21 CFR Part 11?