European Union Device Regulation (EU MDR)

Website https://worldcomplianceseminars.com/upcoming_webinar | Edit Freely

Category Imports, exports, business, Accounts, law

Deadline: February 20, 2020 | Date: February 20, 2020

Venue/Country: U.S.A

Updated: 2020-01-04 19:05:05 (GMT+9)

Call For Papers - CFP

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

Session Highlights:

• 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 is a consultant retired from industry after 20 years in management of 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.