medical-software-whitepaper Archives - Page 2 of 2

Requirements of the ISO 13485 – A comprehensive guide

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...

Approval & certification of software medical devices (MDR)

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...

Guideline for the development of medical apps: What manufacturers need to look out for

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...