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 ...

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, ...

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 ...

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.

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 ...

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 ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

<p>As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing ...