The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

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 ...

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

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

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

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 ...

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