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 ...

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

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 ...

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 ...

Recent U.S. elections and President Donald Trump’s new appointments have drawn global attention. Entire industries and nations brace for potential changes in their trade relationships with the world’s ...

The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It ...

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 ...