The Medical Devices Introductory Course 2020

Key principles and process overview THE LITERATURE REVIEW

The Organisation for Professionals in Regulatory Affairs

Search strategy

• Must be comprehensive and objective – both favorable and unfavorable data should be included • Must be performed in a logical and methodical manner • Reviewers must be able to determine if all possible data was sought for • HOW?

Use of appropriate search terms

Setting clear inclusion/exclusion criteria

• The process must be documented and included in the CER

The Organisation for Professionals in Regulatory Affairs