Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate ...

The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

This article describes the disadvantages of surgical sutures, advantages of surgical glues/sealants, and the properties of ...

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article ...

Over the past decade, the Supreme Court has made the formerly simple analysis of patent eligibility for diagnostic technologies into a complex mixture of hard-to-reconcile precedents. However, after a ...

This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a series that examines – and prioritizes -- ...