Webinar on Risk Management EU MDR Perspective

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(No Transcript)
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Risk Management EU MDR Perspective

• Risk management is understood as a
  continuous iterative process throughout the
  entire lifecycle of a device, requiring regular
  systematic updating. Though Risk management has
  been a requirement in MDD also, EU MDR places
  greater emphasize on this area. EU MDR has
  provided detailed description on how
  manufacturers should establish, document,
  implement and maintain a system for risk
  management. Risk management system should be
  carefully aligned with and reflected in the
  clinical evaluation for the device, including the
  process of clinical risks that needs to be
  addressed as part of clinical investigations,
  clinical evaluation and post-market clinical
  follow up. Risk Management and clinical
  evaluation processes should be inter-dependent
  and should be frequently updated.
• Considering the importance of risk
  management with EU MDR, this webinar is designed
  to focus on the following aspects of risk
  management in EU-MDR perspective.
• Risk management requirement under MDR
• Risk-Benefit analysis
• Clinical Investigations under MDR
• Expectations above and beyond MEDDEV 2.7.1,
  Rev 4
• Conformity Assessment Procedures.

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About Our Speaker

• Dr C Lessmann, Ph.D.
• Risk Management EU MDR lead, MakroCare
• Register here https//www.makrocare.com/webinar-r
  egistration-for-risk-management-eu-mdr-perspective