by Malte Bucksch | Sep 10, 2024 | medical-software-whitepaper
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the diagnosis or...
by Malte Bucksch | Feb 22, 2024 | medical-software-whitepaper
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...
by Alexander Fenkiw | Nov 10, 2022 | medical-software-whitepaper, Unkategorisiert
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...
by Alexander Fenkiw | Mar 31, 2022 | medical-software-whitepaper, medical-software-whitepaper
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...
by Malte Bucksch | Jan 16, 2019 | medical-software-whitepaper, Unkategorisiert
Medical apps are now being used more and more frequently, e.g. in disease prevention, disease diagnostics, disease treatment or for the monitoring of vital parameters. However, it is not that easy to launch a medical app on the market that is secure and compliant with...