Updated CE Marking Process & ISO 13485:2016 Expectations

6 years ago Posted By : User Ref No: WURUR24409 0
  • Image
  • TypeWebinar
  • Image
  • Location Fremont, California, United States
  • Price
  • Date 09-10-2018
Updated CE Marking Process & ISO 13485:2016 Expectations, Fremont, California, United States
Webinar Title
Updated CE Marking Process & ISO 13485:2016 Expectations
Event Type
Webinar
Webinar Date
09-10-2018
Last Date for Applying
08-10-2018
Location
Fremont, California, United States
Organization Name / Organize By
Netzealous LLC DBA - Compliance4All
Organizing/Related Departments
Compliance Trainings & Seminars for all Industries
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Information Technology

Manufacturing

Medical/Healthcare/Hospital

Location
Fremont, California, United States

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: [email protected]

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00
Registration Ways
Phone
Website
Address/Venue
  Online  Pin/Zip Code : 94539
Official Email ID
Contact
Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: +1-800-447-9407 Email: [email protected]

[email protected]

     +1-800-447-9407
   Fax No: 302-288-6884