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 ...

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 technology sector in Europe is undergoing significant regulatory transformations, particularly in Switzerland and the U.K. These changes are shaping how medical devices are approved, ...

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

This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States. Growth rates per clinical application varies.