There’s a distinct need to create wearables that interweave seamlessly into an individual’s lifestyle, encouraging adherence ...

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

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

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

<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 ...

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

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

Over the past 25 years, the software development landscape has undergone significant transformations, driven by technological advancements and evolving business needs. From the rise of the internet ...

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, ...

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 — ...

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.

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...