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 ...

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 ...