Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States.
The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms.
Micro molding demands tight tolerances for precise parts in medical, electronics, and micro-systems. Vertical integration ...
The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical ...
Explore two studies that indicate for a properly-assembled vial containment system, good CCI performance can be achieved with ...
The regulatory affairs (RA) function is responsible for the approval and ongoing regulatory compliance of drugs and medical technologies. However, regulatory affairs is typically seen as a cost center ...
The scrutiny of extractables and leachables (E&L) from pharmaceutical packaging and delivery systems has intensified ...
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