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, ...
10/22/2019
The safety concept is one of the important concept documents we create during product development. It describes why a device is safe and how safety is ensured in the event of a malfunction. Various aspects are considered, such as mechanical safety. ...
Ensuring the electrical safety of the devices we develop is a key aspect of our daily work. Much has already been written about electrical safety and insulation diagrams in other articles (Part 1 and Part 2). In this article, I would like to... ...
04/15/2019
Reliable systems are of enormous importance to all of us across all industries. Whether in medical technology, the automotive industry, aviation, rail, or even the process industry – we rely on technical systems every day – we call this "reliability." ...
04/08/2019
At some point in the lifecycle process, a change request arises. This necessitates a review of previous activities. What is the best way to handle change requests for software or a system? Because the goal ...
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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