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Literature Reviews for Medical Devices

Level:
Advanced
Area:
Medical Devices
Code:
MDA1
Duration:
03:30:00
Workshop profile:
This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
Objective:
The aim of this workshop is to understand how to write a literature review as part of a CER. Participants will learn how to prepare a literature review to current MEDDEV 2.7/1 rev. 4 requirements.
Content:
The workshop will explain the following: · the role of the literature review in the clinical evaluation of a medical device; · the scope of the literature review; · developing literature search strategies for the subject device and state of the art (current knowledge); · writing the state of the art section; · screening and appraising the literature for the subject device; · data extraction; · analysing and presenting the literature in the CER; · literature disposition; · citing references and listing excluded references.