The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Lets take a closer ...

The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies ...

Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, ...

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

Engaging a development partner early provides critical technical and regulatory insight to avoid costly redesigns and ...

Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and ...

PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is ...

Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.” Over 25 years leading global ...

Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to ...

Bowie-Dick testing is essential for compliance, but the choice between disposable and reusable systems impacts cost, waste, and efficiency. Learn how to balance sustainability with sterility assurance ...