Medical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. Biocompatibility testing evaluates the effect of a medical device on human tissues to determine whether it can cause biological reactions such as toxicity, physiological, immune, or mutation. Biocompatibility testing is a key process to ensure the safety and...
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Proregulations is excited to announce its participation in the 29th CBA Annual Conference, which will be held at the Marriott Washingtonian Center (9751 Washingtonian Blvd, Gaithersburg, MD 20878), on June 9, 2024, 07:45 am - 5:30 pm.
About CBA
The Chinese Biopharmaceutical Association (CBA), founded in 1995, is an independent, non-political, non-profit professional organization...
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People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device...
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Proregulations is a newly emerging regulatory consulting firm that specializes in assisting medical device manufacturers and companies in navigating the complex process of registering their products with the U.S. Food and Drug Administration (FDA). With its comprehensive range of services, Proregulations helps medical devices to enter the lucrative North American market smoothly and...
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The 2024 CPHI North America Conference is scheduled to be held at the Pennsylvania Convention Center in Philadelphia, a heavy industrial city in the United States, on May 7-9, 2024 (local time). Proregulations will participate in CPHI North America Conference, and our booth number is 651.
Please schedule a meeting through our appointment scheduling portal at "2024 CPHI North...
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