Easy Medical Device Blog
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Selling Medical Devices in Brazil (Without Tears): A Straightforward Step-by-Step Guide
Selling medical devices in Brazil goes beyond regulatory compliance. It is a strategic market access decision [...]
by Mateus Lima
Best Tips: ISO 13485 procedures with our free template (Version 2016)
Have you ever been in this situation where you have to create the ISO 13485 procedures (or [...]
by Monir El Azzouzi
How to Register Your Medical Device in Saudi Arabia?
Are you looking for a new market opportunity for your medical device? Do you want to expand [...]
by Monir El Azzouzi
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