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

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

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.

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 ...

In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing. Surrogate surfaces, ...

<p>What&#39;s the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and ...

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>Medical device companies were hit especially hard during the pandemic. In 2023, key inbound considerations for medical device value chains will need to include sourcing strategies that enable ...

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 ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

The global market for laparoscopic devices is currently experiencing substantial growth, driven by several key factors. Laparoscopic surgery, also known as keyhole surgery, or a type of minimally ...