Course Description

Format and Structure of a Medical Device Clinical Investigation Plan/Protocol

Course Description:

This course provides an in-depth review of the content and format of clinical investigation plans in accordance with ISO 14155, 21 CRF 812, and the Japanese ICH. It also examines the subtle differences between regulatory systems.

Learning Objectives:

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

  • Establish an outline of a clinical investigation plan for an international medical device clinical investigation

Who Should Enroll:

Clinical project directors and senior clinical project and regulatory managers are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • ISO 14155: In-Depth Review (series; IDs 61–67)
  • The European Union Regulatory System for Medical Devices (ID 145)
  • The Japanese Regulatory System for Medical Devices (ID 146)
  • US FDA 510(k) Notification Process (ID 92)
  • US FDA Investigational Device Exemption (IDE) Overview (ID 121)

Subject Matter Expert:

42 min

Related resources:

Case studies:

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