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...
Guide to §374a SGB V – Interoperability for DiGA, aids & implants
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...
Approval & certification of software medical devices (MDR)
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...
MDR Guide: Clinical evaluation of software medical devices
“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....
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