by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery. Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
Description Wireless medical telemetry is generally used to monitor a patient’s vital signs (e.g. pulse, and respiration) using radio frequency (RF) communication. These devices have the advantage of allowing patient movement without restricting patients to a bedside...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
Description Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to support health care delivery. Examples of functions that can utilize wireless...
by admin | Dec 15, 2017 | Latest News, What is a Medical Device?
List of FDA Guidance Documents with DH content (NEW) Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug Administration Staff (PDF – 1.2MB) -December 08, 2017 (NEW) Clinical and Patient Decision Support...
by admin | Dec 15, 2017 | Latest Devices, What is a Medical Device?
Software as a Medical Device (SaMD) Software intended for one or more medical uses that may run on different operating systems or in virtual environments. Software run on a hardware medical device is a SaMD when not part of the intended use of the hardware medical...
