Phrasing of the intended purpose for (software) medical devices
How do I actually decide whether my product is a medical device? Where do I start when I want to determine its risk class? And what statements can I use to promote my product in the end? The answers to these and many other questions can be answered on the basis of...
Artificial intelligence (AI) in medical devices – MDR guide (2026)
With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time – also in the field of software medical devices. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this...
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....
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...
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 sets out specific requirements for how you must develop and maintain your software. This applies both to standalone software (e.g., medical apps) and to...
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