ISO 14155: 2011 Medical Device Standard

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ISO 14155_Full_Thumbnail.jpg

ISO 14155: 2011 Medical Device Standard

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This course covers the ISO 14155: 2011 Standard for medical device.

Content includes an overview of the Standard, section 5: Clinical Investigation Planning, section 8: Sponsor Responsibilities, section 9: Responsibilities of the Investigator, section 6: Clinical Investigation Conduct, and section 7: Suspension, Termination, and Close-out of Clinical Investigation.

Course Length: 45 minutes

INTERACTIVE DEMO:

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Includes:

  • Unlimited access to the content for 45 days from your initial day of purchase.

  • Certificate of completion

  • Case Studies

  • Post-Assessment

  • Knowledge Checks

Objectives

  1. Obtain training on ISO 14155: 2011 Medical Device Standard

  2. Recognize how the ISO 14155 Standard applies to activities related to site monitoring and investigator responsibilities

  3. Apply the ISO 14155 Standard to study activities

Audience

All clinical research personnel