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ISO 14155: Clinical investigation of medical devices for human subjects

This course is intended to be an overview of Good Clinical Practices (GCPs) as outlined in ISO 14155 that is intended to be applied worldwide to clinical investigations of medical devices.

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Description

ISO 14155 is intended to regulate clinical investigations of medical devices as required by national, regional and international Health Authorities (HA). This course provides an overview of Good Clinical Practices (GCPs) as outlined in ISO 14155, including a summary of GCP principles, ethical considerations, Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB), informed consent and more. After completing this course, learners should be able to identify the specific requirements of ISO 14155 and identify ways to assess safety, clinical performance and effectiveness of investigational medical devices. 

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Duration

60 minutes

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Library

Clinical: Medical Device

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Functional area

Clinical and Quality

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