Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...

Visit Medbio at Booth #837 to discover end-to-end medical manufacturing solutions trusted by over 1,500 medical customers, including the top 30 global medical device manufacturers. Now partnered with ...

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of ...

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based ...

Per- and polyfluoroalkyl substances (PFAS), widely used in medical devices for their durability, biocompatibility, and resistance to temperature and moisture, are under growing scrutiny. Known as ...

Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure integrity. When assuring the quality of all packaged products, testing ...

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

Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions — and as the administration plans a broader reorganization, the impact will likely grow. One ...

What if a single symbol on your medical device label could determine market access — or trigger compliance gaps across jurisdictions? The recent update to ISO 15223-1 — formalized through Amendment ...

Micro molding is a highly specialized and demanding field of precision manufacturing, critical for industries requiring ultra-small, intricate components. As parts shrink and tolerances tighten, ...