Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, ...

IDEX streamlined a complex fluidic system by designing custom tubing assemblies and color-coded fittings, reducing assembly ...

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports ...

A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and ...

Medical Device ManufacturingMedical device manufacturing includes all aspects of the fabrication of a medical device, from designing a manufacturing process to scale-up to ongoing process improvements ...

It uses an XY-Stage and turntable equipment to provide velocity and positioning information. The SR Series is simple to install and align, and features an easy retrofit to an existing system. The ...

W. L. Gore Associates, Inc. surface-mount technology (SMT) gaskets are EMI shields that can be installed with standard pick-and-place equipment. Gaskets use vendor's GS5200 nickel-filled expanded ...

A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

<p>The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA&#39;s latest efforts to enhance medical device cybersecurity ...

This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...

The proposed FDA regulation for laboratory developed tests (LDTs), as outlined in FDA-2023-N-2177-0001, marks a significant step toward the FDA trying to standardize oversight for these diagnostic ...