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

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

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

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

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

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

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 ...

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 ...

Recent advances in AI, including machine learning, natural language processing, and deep learning models, are transforming rare disease diagnosis.