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 ...

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 ...

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

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

There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives.

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

Aberdeen Technologies, Inc. is an IS09002/QS9000 registered custom molder specializing in insert molding of medical devices which require critical tolerances. Our special Book mold design allows ...

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 ...

Medical device labels play an important role in a device’s life. They are key to market introduction and success, a company’s long-term financial viability, and to patients’ health ...