The IEC 62304 standard and configuration management

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...
How to write instructions for use for medical devices

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?

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...