What is the clinical trial process for medical devices?

Date:2023-02-27
1. Application: Submit an application to the relevant regulatory body in the country where the device will be used. It must include an Investigational Device Exemption (IDE), which outlines the objectives and risks of the proposed clinical trial. 2. Study Design & Protocol: Develop a study protocol that outlines the objectives, design and ethical considerations. 3. Pre-Clinical Testing: Conduct preclinical testing in animals to ensure that the device is safe for use in humans. 4. Ethical Approval & Institutional Review Boards (IRBs): Obtain ethical approval from local ethical review boards and independent IRBs. 5. Investigational Site Selection & Recruitment: Choose clinical sites for the trial and conduct recruitment of trial participants. 6. Trial Conduct: Monitor the trial to ensure that the required data is collected. 7. Data Analysis & Reporting: Analyze the collected data and present the results in the trial report. 8. Regulatory Approval: Submit the trial report to the relevant regulatory body for approval.
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