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

IDEX Health & Science delivers integrated fluidic subsystems that simplify complex life science instrumentation, improving performance, reliability, and speed to market through precision ...

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 ...

USP 382 introduces system-level, function-specific testing for elastomeric components in parenteral packaging, improving container integrity, sterility, and patient safety through enhanced protocols.

Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization ...

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 ...

Whats the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and ...