An overview of the IEC 62304 standard and software safety classifications
If you are developing medical device software, then you will be working closely with the IEC 62304 standard. The number of activities you need to complete according to the standard depend on how harmful your medical device is. This is decided with a software safety...
The IEC 62304 standard and configuration management
IEC 62304 is an essential standard if you are working with the development of medical device software. In this article, you will get an overview of the scope of this standard, along with the configuration management process which will help you keep track of...
A proactive approach to managing safety for electrical medical devices
In this article, we will take a look at how you can manage safety in a simple and effective way when developing electrical medical devices, while at the same time following the IEC 60601 standards. You will also learn why it is critical to identify specific...
How to write instructions for use for medical devices
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. And as such, there are plenty of requirements...
What is new in the 2017/745 MDR?
The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as “… necessary to consolidate the...
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