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UID:2140535:Event:240182
DTSTAMP:20260522T144731Z
SUMMARY:EU Medical Device Regulation (MDR) - Updated CE Marking Proces
 s & ISO 13485:2016 Expectations
DESCRIPTION:This EU Medical Device Regulation (MDR) 90-minute webinar 
 will discuss the recently developed regulation and its impact on the f
 uture compliance and registration of medical devices in the EU.\nIt in
 cludes specific insights from direct involvement and work within the E
 U and the Commission's major improvement objectives to their system to
 day. Areas of change between the prior Medical Device Directive (MDD) 
 and the MDR will be discussed as well as expectations for how to imple
 ment ISO-13485:2016.Learning Objectives:\n\nUpon completion of this co
 urse, attendees will have enhanced knowledge of the ever-changing land
 scape of Medical Device Regulation in the EU\nThe content of this cour
 se is designed to simplify the understanding of requirements and to pr
 ovide attendees with the latest insight on how changes are being viewe
 d and implemented by companies marketing products in the EU\n\nCourse 
 Agenda:\n\nEU Regulatory and Legislative Structure\nEU Definition of a
  Medical Device\n3 EU Directives -> 2 EU Regulations\nKey Agencies Inv
 olved\nWhy the change from Directives to Regulations?\nOverview of CE 
 Marking Process & Changes Resulting from the EU MDR\nUpdated Role of t
 he Notified Body\nMedical Device Classifications\nEssential Requiremen
 ts -> Safety & Performance Requirements\nIntegration of Risk Assessmen
 t / Risk Management\nConformity assessment\nDevice Vigilance & Reporti
 ng System\nMDR Overview (by Article & Annex)\nISO 13485:2016 Updates\n
 Medical Device Single Audit Program (MDSAP)\nGlobal Impact of ISO 1348
 5:2016 Certification and CE Marking\nTips on Working with Regulatory A
 uthorities\n\nWho Will Benefit:\n\nExecutive Management\nQuality Assur
 ance\nRegulatory Affairs\nClinical Research and Medical Operations\nPr
 oduct Development\nManufacturing / Distribution\nMedical Device R&D\nC
 linical Trial Supply\nCRO's\n\n\n\n\nSpeaker ProfileRobert J. RussellĀ
  is a Global Regulatory and CMC expert with 28 years of prior industry
  experience in international regulatory management and compliance, glo
 bal business development and global supply chain management. Mr. Russe
 ll formerly held senior leadership positions, in these functional area
 s, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.His experienc
 e and knowledge span Healthcare Authority's requirements and regulator
 y processes across Life Science products. For the past 18 years, Bob h
 as been President & CEO of RJR Consulting, Inc. The company assists th
 e pharmaceutical, medical device and biotech industries in understandi
 ng Regulations affecting compliance and in conducting product registra
 tions with their clients in more than 95 countries. He holds a BS / MS
  in Chemistry.\"\n\nEvent link:\nhttps://www.compliance4all.com/webina
 r/-502821LIVE?channel=%20medtechiq.ning_2020_SEO\nContact Info\nNetzea
 lous LLC,DBA -Compliance4all\nEmail: support@compliance4All.com\nPhone
 : +1-800-447-9407\nWebsite: https://www.compliance4all.com/\n\n\nFor m
 ore information visit https://medtechiq.ning.com/events/eu-medical-dev
 ice-regulation-mdr-updated-ce-marking-process-amp
DTSTART;TZID=America/New_York:20200221T100000
DTEND;TZID=America/New_York:20200221T130000
CATEGORIES:online, event
LOCATION:Online
WEBSITE:https://www.compliance4all.com/webinar/eu-medical-device-regul
 ation-(mdr)---updated-ce-marking-process-&-iso-13485:2016-expectat
 ions-502821LIVE
URL:https://www.compliance4all.com/webinar/eu-medical-device-regulatio
 n-(mdr)---updated-ce-marking-process-&-iso-13485:2016-expectations
 -502821LIVE
CONTACT:+1-800-447-9407
ORGANIZER:Compliance4all
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/2647295700?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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