Course Description

Performing a Clinical Evaluation for EU Market Approval: Step by Step Primer

Course Description:

This course reviews the new guidelines for clinical evaluations and outlines the steps for producing reports.

It covers the following topics:

  • Device claim presentations
  • Predicate device and concept of equivalence criteria
  • Clinical data identification
  • Critical assessment
  • Selection
  • Determining conformity for CE marking or clinical investigation designs

Watch the Course Trailer:

 

 


Learning Objectives:

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

  • Comprehend and apply the MEDDEV 2.7.1 guidelines concerning clinical evaluations of medical devices
  • Define device performance and safety claims
  • Differentiate criteria for predicate devices and concept of equivalence
  • Illustrate clinical data identification and appraisal
  • Interpret critical assessment, selection, and appraisal in determining conformity with the applicable MDD

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 encouraged 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)
  • Clinical Evaluation for EU Market Approval: Literature Review (ID 120)

Subject Matter Expert:
Monica Tocchi

Duration:
58 min

Release date:
07/23/2010

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 238.00
Premium Account: € 178.00

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