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...
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....
DiGA: Guidelines for demonstrating positive supply effects
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....
IEC 62304: Software life cycle processes for medical devices
IEC 62304 specifies processes and activities that you must observe when developing software as a medical device. It places specific requirements on how you must develop and maintain your software. This applies both to stand-alone software (e.g. medical apps) and to...
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