Med Device Online4d
The ABCs Of PCCPs (Predetermined Change Control Plans)
The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms.
Med Device Online4d
The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
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 ...
Med Device Online5d
Verticle Integration Drives Success In Tolerance Attainment For Micro Molding
Micro molding demands tight tolerances for precise parts in medical, electronics, and micro-systems. Vertical integration ...
Med Device Online6d
DSP Workshop
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 ...
Med Device Online7d
Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices
The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical ...
Med Device Online11d
A Look Inside The Growing U.S. Market Landscape For Surgical Navigation & Robotics
Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States.
Med Device Online13d
Improve Speed To Market By Mitigating Vial And Stopper Incompatibility
Explore two studies that indicate for a properly-assembled vial containment system, good CCI performance can be achieved with ...