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 FDA considers threat modeling fundamental in your premarket submission and expects you to include system level risks in its creation and deployment. But how do we go about threat modeling for our ...

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

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 ...

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