by Alexander Fenkiw | May 3, 2022 | Unkategorisiert
Attention manufacturers of electronic aids, implants and DiGA! From mid-2024, a new legal requirement will apply to improve interoperability between medical devices and digital health applications (DiGA) approved by the BfArM: §374a SGB V Specifically, this involves...
by Alexander Fenkiw | Mar 31, 2022 | medical-software-whitepaper
How does medical device approval for software work? How long does this process take? And what are the costs involved in certification? The path to medical device approval is also complex for software products. It is therefore advisable to deal with the...
by Alexander Fenkiw | Jan 24, 2022 | Unkategorisiert
“Clinical evaluation? No problem!” “A doctor was recently interviewed in the Süddeutsche Zeitung! She clearly stated that mindfulness apps help with depression. We can refer to that, can’t we?” Unfortunately, it’s not that simple....
by Alexander Fenkiw | Jun 18, 2021 | Unkategorisiert
What is the point of a DiGA if it does not improve patients’ lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register....