by LaraBoll | May 19, 2023 | Unkategorisiert
Having fulfilled all regulatory parameters and been entered in the central DiGA directory, have all hurdles been cleared and a successful market entry guaranteed? Unfortunately not quite. Contrary to some wishful thinking, entry in the central DiGA directory itself...
by Malte Bucksch | Apr 12, 2023 | Unkategorisiert
The implementation of a digital health application (DiGA) involves effort and costs that should ultimately be worthwhile for your company. And indeed – many certified DiGAs that make it onto the market show extremely positive prescription and sales figures....
by Alexander Fenkiw | Jan 18, 2023 | Unkategorisiert
Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...
by Alexander Fenkiw | Dec 30, 2022 | Unkategorisiert
If you are developing software that qualifies as a medical device under the Medical Device Regulation (MDR), validation is one of the most critical issues. Successful validation of your software is an absolute prerequisite for bringing your medical device to market....
by Alexander Fenkiw | Nov 10, 2022 | Unkategorisiert
Anyone involved in the development of software medical devices is certainly no stranger to the term “Quality management system” (QMS). You may also have heard of ISO 13485 in this context. ISO 13485 is a standard that defines the requirements for a quality...
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...