How to define IEC 60601 test plans and protocols for medical devices
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,...
Design Control for medical devices – what is it and why you should do it
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...
What is a medical device?
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...
How to perform a medical device design review
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...
How to identify and manage critical components
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...
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