In medical technology, technical errors in a device can have fatal consequences for operators or patients. Therefore, a safety architecture is generally required during the approval process for medical devices. It is important to consider the issue of functional safety right from the design stage. ...
08/08/2022
If you are certified according to DIN EN ISO 13485, or if that is your goal, you have probably already come across tool validation. Perhaps this article can help you and shed some light on the subject. Why do you need ...
06/21/2022
Intro We've already discussed code reviews in one or two blog posts. So why another article on the topic? Now: This article is about a process we use when conducting code reviews. ...
03/24/2022
Many technical applications require the time synchronization of various system components. We at MEDtech have frequently encountered this topic. In this blog, I would like to first discuss time synchronization in general and then introduce a method ...
11/29/2021
1, 2 or 3 is not only the question in a well-known quiz show for children on public television, but also for companies that want to market a medical device in the EU. The MDR provides in Article ...
06/16/2021
References: When IEC 62304 or ISO 14971 is mentioned below, the following editions are meant: IEC 62304:2006 + A1:2015 and EN ISO 14971:2012 Problem: We are developing software/firmware that is a component of a medical device. The software (or the ...
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