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 ...

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

No matter how hard you try, how strong your processes are, or even how good your prototype is, when you transfer a device into production, it’s a bit like a Sunday morning when you decide to make ...

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 ...

In medical device design, simplicity isn't just a luxury — it’s a necessity. When creating devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. Medical ...

The issue of misuse of medical devices is a major one. Whether it happens by patients using a device at home without proper training or by surgical staff looking for a faster way to operate a device, ...

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 ...