European Union Device Regulation (EU MDR)
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The MDR is effective May 2024 leaving limited time to prepare. These new and expanded requirements will be explained.
Attendees should have a reasonable understanding of FDA regulations.
Why should you attend?
The EU MDR will be effective in May 2024. Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance. There is extensive preparation necessary. This webinar will explain what needs to be done to meet the deadline.
Course Outline:
• EU MDR objectives
• QMS requirements
• Device classification changes
• Documentation requirements
• Clinical evaluation requirements
• UDI and labelling requirements
• Post market surveillance
• New Notified Body obligations
• Human Factors/ Usability requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Engineers
• Regulatory personnel
• Quality Assurance personnel
• Marketing
• Management
• Importers of medical devices
• Distributors of medical devices
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
Contact Us
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