The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the ...

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 ...

Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States.

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 ...

Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in ...

Laser welding machines can safely and precisely weld thin wires of difficult-to-weld materials like stainless steel and ...

The MathWorks, Inc. has unveiled a new version of its DSP Workshop The MathWorks, Inc. has unveiled a new version of its DSP Workshop. The new version, which is based on the updated MATLAB 5.2 and ...

Recently, Latin America has emerged as a promising frontier for medical device clinical trials, with Chile at the forefront of this development. The country's robust healthcare infrastructure and fast ...