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 ...

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 ...

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 ...

ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The ...

Despite the fact that medical device software can evolve far faster than traditional medical hardware, manufacturers must go through the same resubmission process for a new software version as they ...