Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape ...

Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, ...

Hogge Precision, a leading provider of high-precision manufacturing solutions, today highlighted its advanced medical CNC ...

GodFather malware mimics and manipulates real financial apps on Android devices, exposing sensitive data without user ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

Federal authority to regulate cosmetics remained largely unchanged until, on December 29, 2022, President Biden signed the ...

The University of Twente is introducing its first MDR-compliant open-source medical device: the 3D base plate. This open-source initiative provides an alternative route to low-risk medical devices ...

The introduction of the Person Responsible for Regulatory Compliance (PRRC) role mandated under the Medical Device Regulation (MDR) 2017/745 and the In-vitro Diagnostic Device Regulation (IVDR ...

Unlike traditional medical devices, which are static once approved, AI-enabled devices continuously learn and adapt based on new data. This constant evolution creates a regulatory gray zone.