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.
Clinical: Medical Device
Clinical and Quality
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