All medical devices sold in the United States are regulated by the U.S. Food and Drug Administration (FDA). More specifically, any medical device manufactured, repackaged, relabeled, and/or imported by any company or firm to sell in the U.S. has to meet FDA regulations.
Medical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in… Read more »
One of the most important phases of a medical product development life cycle is the relationship between your company’s validation expert and the original equipment manufacturer (OEM) of your medical product. It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the… Read more »
Deciding on the ideal medical contract manufacturer (CM) can be a difficult process, as there are many aspects to consider. Medical device CMs play a critical role in the medical device manufacturing process for original equipment manufacturers (OEMs) whether it’s a need for casting and molding, R&D design, or custom packaging. As a medical instrument… Read more »