Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018

  • 09 Oct 2018
  • Webinar

Description

Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018 is a webinar that covers topics such as:

  • EU Definition of a Medical Device
  • EU Regulatory and Legislative Structure
  • Key Agencies Involved
  • 3 EU Directives -> 2 EU Regulations
  • Overview of CE Marking Process & Changes Resulting from the EU MDR
  • Why the change from Directives to Regulations?
  • Medical Device Classifications
  • Updated Role of the Notified Body
  • Integration of Risk Assessment / Risk Management
  • Essential Requirements -> Safety & Performance Requirements
  • Device Vigilance & Reporting System
  • Conformity assessment
  • ISO 13485:2016 Updates
  • MDR Overview (by Article & Annex)
  • Global Impact of ISO 13485:2016 Certification and CE Marking
  • Medical Device Single Audit Program (MDSAP)
  • Tips on Working with Regulatory Authorities

Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations 2018 is intended for medical device professionals from:

  • Quality Assurance
  • Executive Management
  • Clinical Research and Medical Operations
  • Regulatory Affairs
  • Manufacturing / Distribution
  • Product Development
  • Clinical Trial Supply
  • Medical Device R&D
  • CRO`s

Past Events

Important

Please, check "Advanced Search Webinars EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device

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