This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for ...

This article describes the disadvantages of surgical sutures, advantages of surgical glues/sealants, and the properties of ...

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 ...

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

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 ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.

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

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation. What does this mean for medical device ...