„"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... ...
05/13/2019
IEC 60601-1 is the standard for general requirements regarding the safety and essential performance characteristics of medical electrical equipment. Anyone involved in the development of medical electrical equipment, whether as a quality manager, project manager, or developer, should be familiar with this standard. ...
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. ...
12/13/2015
The safety of electrical medical systems is a major issue that can affect us all. Almost every day, recalls and warnings for medical devices are published on the website of the Federal Institute for Drugs and Medical Devices (BfArM). ...
Anyone working in the medical technology sector has likely heard of the ISO 13485 standard. It deals with quality management systems for medical devices. But what exactly does this standard contain? In this blog post, I'd like to give you an overview. ...
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