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 ...

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

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 ...

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 ...

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 ...

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, ...

There was a time when the inbound supply chain was perceived as a back-end operation, where no news was good news. Today, when supply chains are expected to provide real customer value, there are some ...

By Edwin Bills, Consultant Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting ...