What is a medical device?

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

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

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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