European Union Device Regulation (EU MDR)

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Presented By Global Wizdom

Wednesday, October 14th at 1:00pm EST

Online sale ends: 10/14/20 at 12:45pm EST

Live -Webinar

Kellogg Center 26 West Dry Creek Circle, Suite 600

Littleton, CO 80120

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Description

The MDR is effective in May 2020 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 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.

Areas Covered in the Session:
• 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

Speaker: Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of the development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis, and software validation for the past 10 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.

Global Wizdom
Contact :1-720-414-3543
https://globalwizdom.com

Presented By

Time

1:00pm to 2:00pm
Doors open at 12:30pm

Price

General Admission: $159.00

Age

21+

Venue

Live -Webinar<br> Kellogg Center 26 West Dry Creek Circle, Suite 600<br> Littleton, 80120

Capacity

100

Info Line

1-720-414-3543