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European Union Device Regulation (EU MDR)
- 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
Overview of the webinar
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 2020 leaving limited time to prepare. These new and expanded requirements will be explained.
Attendees should have a reasonable understanding of FDA regulations.
Who should attend?
- Engineers
- Regulatory personnel
- Quality Assurance personnel
- Marketing
- Management
- Importers of medical devices
- Distributors of medical devices
Why should you attend?
The EU MDR will be effective in May 2020. 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.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.