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...

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 with...

Proregulations is about to participate in DCAT Week 2024, scheduled for March 18-21, 2024 (local time) in New York City.   During DCAT Week 2024, staff at Proregulations will be in Converted Room #1415, Lotte NY Palace Hotel, 455 Madison Ave, New York, NY 10022.   “Welcome to Lotte NY Palace Hotel to meet our team of experts and learn more about our industry compliance...

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 which is...

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...