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, ...

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 ...

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

A leading medical device manufacturer faced the critical task of launching a new product introduction (NPI) for an innovative medical device within a newly established greenfield assembly facility.

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.

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 ...

In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...

<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 ...

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 ...

Over the past decade, the Supreme Court has made the formerly simple analysis of patent eligibility into a complex mixture of hard-to-reconcile precedents. The Supreme Court’s Mayo and Myriad opinions ...