Central Prevention Testing Center (ZPP) – Certification of digital courses
For services that serve prevention and health promotion in accordance with Section 20 SGB V, certification as a DiGA is generally ruled out – after all, this must always be based on specific existing indications. Instead, however, there is another regulatory...
Guide for DiGA marketing and sales
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...
Medical devices in Switzerland: MedDO vs. MDR
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...
Validation of medical device software according to MDR
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....
Requirements of the ISO 13485 – A comprehensive guide
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...
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