Medical devices and Switzerland: what you need to know about MedDO and 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...
ISO 13485 – Guide to requirements and content
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...
Data security & data protection certificates for DiGA
Digital health applications (DiGA) require the following certificates in the area of data protection and data security (in addition to many other requirements) in order to be listed in the BfArM directory: Data security certificate according to BSI TR-03161 Data...
DiPA Guide: Digital Applications for Care
On December 19, 2019, the Digital Care Act (DVG) made it possible for doctors to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. With the Digital Care and Nursing Modernization Act (DVPMG), a counterpart to this was...
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