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, ...

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

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

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 ...

The FDAs proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for ...

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