Clinical research in medical device studies has complexities that span regulatory challenges, product types, and unique statistical analysis and study designs.
From glucose meters to artificial heart valves, the medical device industry produces a broad range of diagnostic and therapeutic devices to treat and prevent numerous patient health conditions.
Critical Advantages of Conducting Clinical Research in Medical Devices
● Devices don’t need to be researched with the same degree of scrutiny as drugs if they show ample safety and effectiveness in confirmatory studies that support a Premarket Approval (PMA) application.
● Clinical trials for medical devices focus on prototype development, while drug trials pay more attention to dose responses.
● As the devices are approved through the PMA application process, a single confirmatory study is often sufficient for approval.
● In clinical studies for devices, a post-approval study generally satisfies long-term data requirements.
● Additional clinical trials are not always required when new iterations of medical device designs are devised.
● When a clinical trial is required for a medical device, it may be possible to derive evidence from sources other than well-controlled clinical studies.
We, at COD Research, help you understand your medical device better with a focus on the vital trial execution requirements and parameters of the smallest device to the most critical lifesaving medical device.
We help understand clinical data strategy’s importance, from preparing ready due diligence datasets for funders to post-market safety surveillance for regulatory authorities.
The COD Research team is experienced in conducting different indications, including hip-joint and knee-joint device trials, phase III to IV Cardiovascular device trials, Endovascular and Gynecology signs.
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We offer unparalleled knowledge, support, guidance, and extremely experienced clinical research professionals to the biotechnology, life science, and medical device industries.
