A product has been successfully approved and is on the market. Can cybersecurity activities now be discontinued? Of course, that's not possible. Cybersecurity risks arise continuously, and it's impossible to identify all vulnerabilities in advance. ...
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... ...
02/25/2019
Which standard must be observed for the approval of an electrical medical device? This article will explain how to determine this for the most important countries (i.e., EU, USA, and China). The article refers to the 60601 family of standards. ...
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