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 ...
05/26/2021
Over 2000 years ago, Ovid wrote, "What lasts long, finally turns out well." Sometimes it's also said, "Good things take time." And then there's the quote, "Everything has an end, only a sausage has two.". ...
05/07/2021
Do you have your measuring instruments calibrated? Do you know what to look out for? As part of our quality management system according to ISO 13485, we also have a process for measuring and testing equipment and calibrate some of our important measuring instruments. We develop new circuits. ...
03/15/2021
Anyone seeking approval for a medical device in the United States cannot avoid the Food and Drug Administration (FDA). Medical devices are becoming increasingly interconnected and are collecting more and more data. ...
06/22/2020
During one of my recent training sessions on requirements engineering, a hardware developer demonstrated in a homework assignment that he understood the topic and was able to write requirements. I found his requirements to be so well-written that..., ...
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