How much does CE certification cost?

For the last 20 years, there has not been a single week in which I have not been asked the following:

“How much does CE certification cost?”

It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.

Polish Medical Device Law Renewed

Polish Medical Device Law Renewed | Graphic by Ellina Goncharova from Alura Group

or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector. 

EU MDR 2017/745 What Changed?

EU MDR 2017/745 What Changed in regard to the Medical Device Directive and how to implement them in your current quality management system?

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?