Articles

When you are presented with a medical device product development project, you do not want to have to ask what the intended use, user needs, design input, design verification, and design validation means. You will learn about this and

Anyone who works in the medical device industry knows that there are numerous requirements you have to follow along the way. Needless to say, this goes for all industries, the topic of this article is related to medical devices.

There are numerous requirements by the competent authorities and notified bodies that medical device manufacturers have to follow. But there is a catch: what exactly is considered to be a medical device? Bear in mind that the article covers only the

Design review is a valuable chance to stop and evaluate the situation when you are developing a medical device. Are the design requirements adequate? Is the design likely to meet these requirements? And, are there any problems that are

The instructions for use is not only something which is referred to in many ways, such as user guide, operating manual or labelling. It is also a document which can be instrumental in achieving safety for a medical device.