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

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

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

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

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

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

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, ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

What if a single symbol on your medical device label could determine market access — or trigger compliance gaps across jurisdictions? The recent update to ISO 15223-1 — formalized through Amendment ...