Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, ...

Brazil is rapidly establishing itself as a powerhouse in medical device innovation. This article shares market opportunities, ...

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 ...

USP 382 introduces system-level, function-specific testing for elastomeric components in parenteral packaging, improving ...

If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory ...

The Mixtruder makes it possible to do both the compounding of the plastic and the tubing extrusion in a single pass with a single screw extruder, at a cost negligibly above that of the tubing line ...

Biocompatibility assessment per ISO 10993 ensures medical device safety by evaluating materials, risks, and biological ...

With ISO TR 24971:2020, the technical committee responsible for the medical device risk management standard has finally addressed the confusion around the policy for risk acceptability criteria and ...

Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore ...

COVID-19 demonstrated the power of rapid diagnostics on a global scale, but the path forward is still complex for in vitro diagnostics (IVD) developers and medtech leaders. This article outlines five ...

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 -- ...

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