Easy Medical Device Blog
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Best Quality and Regulatory Affairs Tools (Medical Devices)
The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new [...]
by Monir El Azzouzi
How to write a Declaration of Conformity? (MDR and IVDR)
The word “Declaration of Conformity” is written 38 times on the EU MDR 2017/745. This is, if I [...]
by Monir El Azzouzi
How to Create a Label as per EU MDR 2017/745?
You will never believe it but the labels are an integral part of your medical devices, [...]
by Monir El Azzouzi
Understanding eIFU for Medical Devices: A Comprehensive Guide
In today’s digital world, the use of electronic instructions for use (eIFU) for medical devices is gaining prominence. The [...]
by Monir El Azzouzi
UDI (Unique Device Identification) : The Complete Beginner’s Guide
The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things [...]
by Monir El Azzouzi