Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

MES software is transforming medical plastics manufacturing by automating compliance and enabling real-time traceability.

Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

Building a medtech startup is a long, costly, and often unforgiving journey. Most don’t make it past five years ...

Microcontroller units (MCUs) are single-chip computers optimized for performing embedded computing tasks like controlling a ...

On track to submit GraftAssureDx™ for FDA review by year-endOn track for commitment to have 20 transplant centers globally ...

Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical ...

Learn how data management strategies for design for manufacturing initiatives can also promote overall operational excellence ...

Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed ...

The third quarter of 2025 closed amid growing macroeconomic strain, policy unpredictability and renewed investor focus on execution risk. While ...

This announcement summarizes Bioretec Ltd's business review for January–September 2025. The complete business review is attached to ...

Surmodics, Inc. , a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that results from a sex-specific analysis of 160 real-world ...