Course Description

Device Accountability

Course Description:

This course reviews the logistics of device accountability, including shipment, ordering, use, disposition, and return of investigational devices. The procedure for returning used devices and potentially biohazardous devices is also included.
This course complies with the requirements of ISO 14155:2020

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Set up and manage a device accountability system
  • Detect non-compliance issues by establishing active verification methods and procedures
  • Take special precautions returning potential biohazardous medical devices.

Who Should Enroll:

Monitors, clinical project managers, investigators, study coordinators, sales and marketing professionals involved in clinical investigations, and clinical professionals from the pharmaceutical industry wanting to understand medical device accountability systems are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

A basic understanding of good clinical practice and the initiation and monitoring processes is required for this course.

Subject Matter Expert:
Danielle Giroud

20 min

Related resources:

Case studies:

Basic Account: € 72.00
Premium Account: € 54.00

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