The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Table I. (click to enlarge) A comparison of different aspects of the U.S., EU, and Japanese medical device markets. Supply factors in the Japanese medical market have contributed to slower approval ...
This story was produced by Dax Janel Valencia and distributed by Next Net. From enabling manufacturers to create highly accurate components to allowing them to develop smaller, more customized medical ...
Figure 1. (click to enlarge) Part-level flow simulation. The diversity and complexity of medical devices are likely to increase with time, as will the associated design risks and manufacturing ...
Customer requirements and regulatory classifications are driving increasingly rigorous quality control protocols in medical device thermoforming, with cleanroom manufacturing emerging as the gold ...
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...
ProMed, a contract manufacturer specializing in liquid silicone rubber (LSR) and highly regulated combination products, has announced new process refinements in the LSR injection molding process ...
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