How to get the EN ISO 14155:2020 standard – download and buy as PDF
Anyone involved with clinical investigation should have a copy of the ISO 14155:2020 standard because it contains everything that is needed on good clinical practice, GCP. But it can be expensive if you buy it in the wrong place.In this article, you will learn where...
EUDAMED logins for beginners
The aim of this article is to give an in-depth explanation of how to perform EUDAMED login. You may want to know how to complete all the steps to register as an actor within the database, or simply to search for the information you need. The video below is a part of...
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...
Free ISO 13485:2016 standard and where to download the PDF
The first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it can be...
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