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Introduction to medical devices world

Level:
Area:
Code:
Sym6.1
Duration:
00:30:00
Workshop profile:
Objective:
Content:
The field of medical devices is a broad one: wheelchairs, contact lenses, X-ray machines and implantable cardioverter defibrillators are all medical devices, but they have completely different uses and pose different risks to the patient, the user and the environment. Thus, medical devices are classified based on their risk profile, affecting the processes required for their market release. Medical writers play a key role in this process: they write some of the most important documents required for market approval such as the clinical evaluation report, clinical investigational plan and clinical investigation report. This introductory session gives an overview of the terminology used, the classification system, the regulatory pathways and the role of medical writers in preparing the documents required.