Blog

Sven Jungmann

SaMD Manufacturer

The SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....

Sven Jungmann

Software 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 Jungmann

Medical Device

A medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...

Sven Jungmann

“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 Jungmann

How to use your real world data (RWD) for clinical studies—Taking a page from the FDA’s playbook II

In 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 Jungmann

How to contribute to the digital transformation of clinical trials

An overview for digital health entrepreneurs Digital innovation will transform clinical trials. It’s inevitable…still, innovators need to...