- Scenario
You are working for a company which previously developed a new medical device (MD) or in vitro diagnostic
medical device (IVD-MD).
You are responsible for designing a clinical trial to ensure the device’s safety and efficacy. The successful
completion of the trial is a requirement for market approval. - Your Task
Design a clinical trial for the device that you have already described in your coursework.
Prepare a power point presentation that outlines the research question and clinical trial design that you would
be using for your device to ensure its safety and efficacy.
Justify your choices. To help you with your task, consider the seminar presentations and resources discussed
in term 2.
Your presentation should include the following sections:
Introduction to your medical device
Problem the medical device addresses
Working principle
Classification
Note: This section should be very brief, because it was already covered in the CWK ( the one that you wrote
before, I also upload it). This is simply to remind the audience and should not be copied from the CWK
submission.
Research question
Describe the research question that you are trying to answer.
Justify why this is important to ensure your device’s safety and efficacy.
Describe the clinical trial design
Consider standards and regulations for clinical trial design
Consider standard protocol items
Consider controls and bias
Consider patient involvement and recruitment
Consider and justify the clinical trial phase
Presentatio.
Welcome to Legit Writing
