Netzealous LLC DBA - Compliance4All, Online
2018-10-02
Overview: It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.
Learning Objective: Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU
Areas Covered in the Session: EU Regulatory and Legislative Structure EU Definition of a Medical Device 3 EU Directives -> 2 EU Regulations Key Agencies Involved Why the change from Directives to Regulations? Overview of CE Marking Process & Changes Resulting from the EU MDR Updated Role of the Notified Body Medical Device Classifications
Who Will Benefit: Quality Assurance Regulatory Affairs Clinical Research and Medical Operations Product Development Manufacturing / Distribution Medical Device R&D Clinical Trial Supply
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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