Post-market surveillance as a medical device requirement in the EU
Dealing with post-market surveillance, or PMS, is a very important part of having medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device...
The EUDAMED database
The main purpose of the EUDAMED database is to enhance traceability, cooperation, and transparency regarding medical devices in EU. The database is huge and has been split up into six different modules with specific purposes. This article will cover the areas that...
Conformity assessment procedures for medical device manufacturers
According to most manufacturers, the notified body conformity assessment is the most challenging part of the CE marking process. This article outlines the general setup of the conformity assessment procedure. This video is an excerpt from the online course...
Authorised representatives, importers and distributors under the MDR
This article presents an overview of different stakeholders and the concept of the economical operators in relation to the MDR. The following video, which is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745, explains the topic...
UDI requirements for medical device manufacturers in the EU
This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. If you would like to know more about the UDI requirements, please take a look at the video below. The video is...
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