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 ...

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 ...

The Lee Company's novel disc pump family, including the UltraSlim (US) Series, offers high-performance, quiet, and compact pressure/vacuum generation with optional electronics. The integrated ...

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

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 ...

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 ...

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, ...

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 ...

The least expensive tester and the most simple to setup and operate The least expensive tester and the most simple to setup and operate. Sprint-GT is perfect for those situations where simplicity and ...