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ISO 14155 2020 New Responsibilities of Sponsor/CRO

$99.00

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.

Description

Why take this course

To gain knowledge of and adhere to new regulatory standards set forth in the conformity assessment of medical devices.

What I will learn

This tutorial provides an overview of the main changes introduced by ISO 14155:2020 on:

  • Outsourcing of duties and functions
  • Clinical Quality Management
  • Clinical Investigation Planning and Conduct
  • Communication with regulatory authorities

Skills I will gain

You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the standard

 

TOPICS

  • Introduction (00:01:00)
  • Who are sponsor and CRO? (00:02:52)
  • Documents and materials preparation (00:01:48)
  • Conduct of Clinical investigation and monitoring (00:02:20)
  • Safety evaluation and reporting (00:02:21)
  • Clinical investigation close-out activities (00:01:00)
  • Responsibilities of the CRO (00:05:04)

  • Final Test – ISO 14155 2020 New Responsibilities of Sponsor/CRO
  • Certification

Additional information

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