91705-Medical Devices and Diagnostics

Introduction

You have watched the documentary about the vaginal mesh implants and discussed the various points of view arising from the use of a particular implantable device. The case was an example of a device that failed despite being approved for clinical use by the relevant regulatory bodies. Evidence of clinical trials was an essential part of the approval process

The task of this assignment is to critically review scientific and clinical evidence (particularly the primary clinical evidence) relating to an implantable medical device of your choice. Reports such as this, where a scientific opinion is required, are used within the legal system to argue for or against a case.

There are many implantable devices on the market, including pacemakers, defibrillators, infusion pumps, and knee joint prostheses. In choosing the device, ensure it satisfies the definition of a medical device (Lecture 1 notes).