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    Updated CE Marking Process & ISO 13485:2016 Expectations

    View: 136

    Website https://www.compliance4all.com/control/w_product/~product_id=502131LIVE?channel=ourglocal_Oct_2018_S | Want to Edit it Edit Freely

    Category Executive Management, Quality Assurance, Regulatory Affairs

    Deadline: October 08, 2018 | Date: October 09, 2018

    Venue/Country: Online, U.S.A

    Updated: 2018-08-07 14:21:31 (GMT+9)

    Call For Papers - CFP

    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: supportatcompliance4All.com


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.