Loading Purplepass...
Updated CE Marking Process & ISO 13485:2016 Expectations
Presented By Netzealous LLC DBA - Compliance4All
Tuesday, October 9th at 10:00am PST
Online sale ends: 10/09/18 at 9:00am PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539
-= series =-
Buy Tickets
|
Talent
Description
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 Speaker Profile: Robert J. Russell For the past 9 years, He has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. 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 Additional Information
https://www.compliance4all.com/control/w_product/~product_id=502131LIVE?channel=purplepass_Oct_2018_SEO
|
Presented By
10:00am to 11:30am
General Admission: $150.00
21+
50 18004479407 UPCOMING EVENTS
PAST EVENTS
Wednesday, August 15th
Online Past Event
|
