The Medical Device Industry is currently transitioning from the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) 2017/745. As an industry we need to progress through this transition period in order to keep our products on the European Market and retain our CE mark. It is important therefore that we understand the MDR requirements and the key changes this entails for our products so that we can navigate through this change.
This course will look at steps involved in the CE marking process through the MDR (what remains the same, what has changed) as well as other key changes that are required. This course will also link the ISO 13485:2016 quality management system (QMS) requirements to the MDR QMS requirements but emphasizing the importance of the MDR as a legal requirement. This course will break down the MDR requirements into something more manageable and participants will gain the skills to be able to apply the requirements to their own products and understand the language used within the document.Collapse
(includes course documentation).