Course Description

Clinical Evaluation for EU Market Approval: Literature Review

Course Description:

This course focuses on literature review reports, an essential part of the clinical evaluation process that uses existing data from comparably marketed products to assess and justify performance and safety claims of medical devices being put on the market.

This course examines the full scope and methodology for evaluations of existing data, and how to present the relevant results based on MEDDEV 2.7.1 guidelines.

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Learning Objectives:

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

  • Comprehend and interpret the MEDDEV 2.7.1 guideline requirements and methodology for critical reviews of existing data
  • Set up a methodology and define appropriate existing data
  • Describe device performance and safety claims
  • Select predicate devices to substantiate claims
  • Conduct a literature search and review (literature search protocol)
  • Write a report with valid conclusions

Who Should Enroll:

Senior clinical and regulatory managers, clinical research directors and vice presidents, medical writers, regulatory affairs directors, and regulatory affairs vice presidents involved in clinical evaluation strategic planning for the EU and medical device global market access are all welcome to participate in this course.


Prerequisite Knowledge/Requirements:

The following courses are required:

  • The European Union Regulatory System for Medical Devices (ID 145)
  • ISO 14155: 2011 - A Summary Review (ID 144)
  • Clinical Evaluation for EU Market Approval: Process and Regulatory Background (ID 116)

Subject Matter Expert:
Monica Tocchi

Duration:
50 min

Release date:
07/02/2010

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 205.00
Premium Account: € 154.00

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