Lately, there has been a growing amount of bad news regarding the intrusion of information technology (IT) into hospitals and medical devices. After servers, routers, and cars, an anesthesia machine was also hacked. And hospital staff have ...
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). ...
11/25/2015
What specific requirements are placed on systems engineers in medical technology? Are there differences compared to other industries? As a systems engineer in medical technology, I would like to share my experiences in this blog post. Regulatory requirements, processes, standards, and approvals. ...
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. ...
08/13/2015
Recently, a reader of the blog and a good colleague recommended a book to me that I consider to be special. The book is entitled “Medical Instrument Design and Development” and is written by Claudio Becchetti and ...
08/03/2015
What is a system? What initially sounds like a simple question can sometimes be quite complex. Because the question doesn't have a single, definitive answer. The answer depends on the perspective and the developmental context. But why should ...
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