Feb 22, 2021 | Articles |
No matter what kind of medical device you are working on, there are some general requirements related to safety which will apply to your medical device, or the development process of that device. This article will introduce the general safety requirements, as defined...
Feb 17, 2021 | Articles |
This article will go over the process of writing test plans and protocols for medical devices in line with the IEC 60601 standard. These documents are essential in order to demonstrate that your medical device meets the established requirements. In the video below,...
Jan 26, 2021 | Articles |
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. When it comes to requirements, there is...
Jan 25, 2021 | Articles |
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 basics, and you...
Jan 21, 2021 | Articles |
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 yet to be identified? In this...
Jan 15, 2021 | Articles |
This article will help you in identifying and managing critical components. The term critical components is used to identify safety-related components in the test report form as required by clause 4.8 of the standard. Critical components are an important topic –you...