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DTSTART:19700308T020000
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UID:2140535:Event:80139
DTSTAMP:20260415T012722Z
SUMMARY:Updated CE Marking Process & ISO 13485:2016 Expectations
DESCRIPTION:Overview:It includes specific insights from direct involve
 ment and work within the EU and the Commission's major improvement obj
 ectives to their system today. Areas of change between the prior Medic
 al Device Directive (MDD) and the MDR will be discussed as well as exp
 ectations for how to implement ISO-13485:2016.\nLearning Objective:\nU
 pon completion of this course, attendees will have enhanced knowledge 
 of the ever-changing landscape of Medical Device Regulation in the EUT
 he 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 produc
 ts in the EU\nAreas Covered in the Session:EU Regulatory and Legislati
 ve StructureEU Definition of a Medical Device3 EU Directives -> 2 EU R
 egulationsKey Agencies InvolvedWhy the change from Directives to Regul
 ations?Overview of CE Marking Process & Changes Resulting from the EU 
 MDRUpdated Role of the Notified BodyMedical Device Classifications\nWh
 o Will Benefit:Quality AssuranceRegulatory AffairsClinical Research an
 d Medical OperationsProduct DevelopmentManufacturing / DistributionMed
 ical Device R&DClinical Trial Supply\nSpeaker Profile:Robert J. Russel
 l For the past 9 years, He has been President of RJR Consulting, Inc. 
 The company assists the pharmaceutical, medical device and biotech ind
 ustries in understanding and complying with International Regulations 
 affecting compliance, new product development, manufacturing and quali
 ty assurance.\nEvent Fee: One Dial-in One Attendee Price: US $150.00\n
 Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Ema
 il: support@compliance4All.com\n\nFor more information visit https://m
 edtechiq.ning.com/events/updated-ce-marking-process-amp-iso-13485-2016
 -expectations
DTSTART;TZID=America/New_York:20181009T100000
DTEND;TZID=America/New_York:20181009T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02131LIVE?channel=medtechiq_Oct_2018_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50213
 1LIVE?channel=medtechiq_Oct_2018_SEO
CONTACT:Event Manager
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562019286?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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