The course is designed by a carefully selected panel of Medical Devices experts bringing together years of experience & knowledge.
You will need these courses if you are jointly or fully responsible for regulatory compliance working in an organisation involved in any aspects of medical device manufacturing, designing, marketing or the supply chain and you want to understand and be able to apply the requirements of the new regulation EU 2017/746.
This 1 day course will provide a basic overview of the requirements of EU 2017/746 and the CE marking approach for medical Devices covering important steps such as:
- Why are we moving from a Directive to a regulation, including understanding the background to the changes
- To identify what the important changes are and their relevance to you as a manufacturer
- Understand what the new regulation is trying to achieve, its key objectives and purpose
- Understanding the scope & definitions of the IVDR
- Understanding the classification rules and applying them to choosing your conformity routes
- To start the process of building your transition plan for certification to the new regulation.
Finally the course will discuss at a high level the hot topics such as, Technical Documentation, Post-market Surveillance, Clinical Evidence, Supply Chain and Unique Device Identification.
Book a Training Course for your Medical Device Regulation
For pricing please send us an enquiry by completing the form and we will get in touch with a quotation