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Davos Inc. Phase Mesh Protocol DVLHE011Version 4.0 October 30, 2017CLINICAL STUDY PROTOCOL Title:A Prospective, Multimeter Study of Phase Mesh for Ventral or Incisional Hernia Repair. Protocol Number:DVLHE011Study
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Identify the purpose and objectives of the post-market prospective multi-center study.
02
Design the study protocol including study population, inclusion/exclusion criteria, endpoints, sample size calculation, and statistical analysis plan.
03
Obtain ethical approval from the Institutional Review Board (IRB) or Ethics Committee.
04
Recruit study sites and investigators to participate in the study.
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Who needs a post-market prospective multi-center?

01
Medical device manufacturers who want to gather post-market data on the safety and effectiveness of their products.
02
Regulatory authorities who require post-market surveillance studies to monitor the performance of medical devices in real-world settings.
03
Healthcare providers who want to assess the long-term outcomes of using a specific medical device in their practice.
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Patients and patient advocacy groups who are interested in understanding the real-world performance of medical devices.
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A post-market prospective multi-center is a study conducted after a medical device has been approved and is on the market to monitor its safety and effectiveness.
The manufacturer or sponsor of the medical device is typically required to file a post-market prospective multi-center study.
To fill out a post-market prospective multi-center, the manufacturer or sponsor must provide detailed information on the study design, objectives, endpoints, and patient population.
The purpose of a post-market prospective multi-center is to gather additional data on the safety and effectiveness of a medical device in real-world clinical settings.
Information such as adverse events, patient outcomes, and device performance must be reported on a post-market prospective multi-center.
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