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... ...
01/07/2021
Does RoHS mean anything to you? The abbreviation stands for "Restriction of Hazardous Substances," with the official German name "Restriction of the use of certain hazardous substances in electrical and electronic equipment" [3]. By now, I think every electronics developer is familiar with the term "RoHS." But ...
It's always interesting to think outside the box – how is hardware developed in other industries? One of the most successful fields of engineering is aircraft technology. According to the website planecrashinfo.com, the number of accidents has decreased from the ...
05/08/2020
Application of risk management to medical devices The third edition of ISO 14971 was published in December 2019. This article summarizes the standard and discusses the changes in the standard. Why a new edition? According to ISO, ...
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