Sven JungmannDec 26, 20211 minSaMD ManufacturerThe SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....
Sven JungmannDec 26, 20211 minSoftware as a Medical Device“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from...
Sven JungmannDec 26, 20211 minMedical DeviceA medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...
Sven JungmannDec 26, 20212 min“Taking individualized medicine to a new height”Eric Topol on the wireless future of medicine In this TEDMED Talk, Eric Topol, MD, discusses the bright future of wireless and remote...
Sven JungmannDec 26, 20212 minHow to use your real world data (RWD) for clinical studies—Taking a page from the FDA’s playbook IIIn a previous insight, we discussed how to evaluate if your real-world evidence (RWE) is good enough. In this one, let’s take a different...
Sven JungmannDec 26, 20214 minHow to contribute to the digital transformation of clinical trialsAn overview for digital health entrepreneurs Digital innovation will transform clinical trials. It’s inevitable…still, innovators need to...