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

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 ...

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 ...

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 ...

Visit Medbio at Booth #837 to explore full-service medical manufacturing backed by 100+ years of expertise, trusted by top global device makers.

Battelle offers comprehensive medical device development solutions, guiding products from initial insight to post-launch management. With over 65 years of experience, Battelle helps clients navigate ...

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

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, ...

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 ...