The course is designed by a carefully selected panel of In Vitro Diagnostic 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 2 day course will explain in detail the requirements of EU 2017/746 and the CE marking approach for medical Devices including its legal and operational basis
The course is designed to guide you a systematic approach to implementing the new regulations covering important steps in the CE process such as:
- Understanding the scope & definitions of the MDR
- Understanding the classification rules and applying them to choosing your conformity routes
- Identify the regulatory significance of a robust Quality Management System
- Understand the new requirements when creating technical documentation to support the product throughout its life cycle
- We will take a look at the General Safety and Performance Requirements checklist in Annex I
- Understand the level of Clinical Evidence and Performance Evaluation necessary to demonstrate conformity
- Learn how to develop a robust and proactive post market surveillance system under the new MDR including vigilance reporting and monitoring
- Identify how the Risk Management System integrates into this regulation
Finally we will gather the business impacts of the regulation and start to develop a transition plan in the shape of project which will support you through the CE marking process under the new regulation.