Course Description

Designing a Strategic Medical Device Clinical Investigation Plan/Protocol

Course Description:

This course focuses on designing thorough clinical investigation plans using a logical, step-by-step approach. It covers basic strategic claims, how to develop a design so that it translates valid and feasible endpoints, and guidance and regulatory documents and requirements to ensure that the final results are aligned with market needs.

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Learning Objectives:

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

  • Define claims as starting points for study designs
  • Interpret the information found in guidance and regulatory documents and plan an appropriate study design for a future medical device investigation
  • Implement feasible methods for realistic endpoints
  • Build clinical investigation plan designs that are acceptable to investigators, patients, and regulators

Who Should Enroll:

Clinical project directors, managers, and senior regulatory managers are all encouraged 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:
Catherine Kusnick
Danielle Giroud

90 min

Related resources:

Case studies:

Basic Account: € 454.00
Premium Account: € 341.00

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