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 ...
Update Notice (May 23, 2025) This article is based on AAMI TIR57:2016, an important guideline for cybersecurity risk management in medical devices. Since 2023, TIR57 has been supplemented by the new standard ANSI/AAMI SW96:2023, which formalizes the content and ...
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. ...
„"MDR," "MPG," "60601," and "62304": Experienced colleagues constantly throw these terms around when developing medical electrical devices. For a newcomer to this field, the standards and regulations can quickly become confusing. In the following article, I would like to... ...
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