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 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.

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

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 ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

Rare diseases affect over 300 million people worldwide, with more than 7,000 identified conditions. 1 Despite this prevalence, patients often face a diagnostic odyssey lasting 5 to 7 years, leading to ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

Adaptive AI heavily utilizes large language models (LLM) to imitate human rationality and communication, and sometimes in a more efficient way. In the United States, the FDA has addressed the recent ...