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 18:41:26 (GMT+9)

Call For Papers - CFP

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.

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