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Model Credibility Considerations for Particulate Testing
Downstream embolization of particles generated by intravascular devices poses a risk to patients. The generation of particulate...
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Using a Simulated Use Approach to Determine Particulate Generation
There is increasing evidence particulate matter from medical devices is creating unintended clinical risks following use. Understanding...
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De-risking medical devices and ensuring patient safety with appropriate controls
Great ideas for medical devices can come from anywhere. Translating that idea into a viable safe and...
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Practical European MDR Activities and Strategies
Listen to our webcast to learn about practical European MDR activities and useful strategies.
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Top 10 Challenges in Evaluating Medical Devices for MRI Safety
Several safety concerns exist when patients with metallic implants require diagnostic MRI. These concerns include magnetic forces,...
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Quantifying the Geometry of Vascular Access
The human vasculature has been accessed with minimally invasive techniques for almost 100 years. The first procedure...
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Use of a NURBS-based, fully body anatomy and FEA model to evaluate RF-induced heating during MRI Imaging
Purpose: Previous studies using computational methods to evaluate RF-induced heating during MR imaging focused on predicting specific...
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RF induced heating during MRI: Evaluation of a passive implant in an anatomical model
Introduction: RF induced heating in anatomical models using a coupled Electromagnetic (EM)/thermal FEA approach and NURBS-based geometry...
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Radiopacity Testing
Radiopacity is the ability of a material to impede the passage of x-rays, thus allowing for visibility...
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Radiopacity
Radiopacity refers to the relative inability of electromagnetic radiation, specifically x-rays, to pass through a particular material....