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

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

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 ...

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 ...

This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in ...

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

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

When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple.  ...

Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.