Knowledge Bank

KORU Medical Systems has received FreedomEDGE infusion system FDA clearance from the US Food and Drug Administration, allowing the device to be used for administering...

Overseeing the intricate web of global providers for raw materials and contract services is essential for ensuring product safety and maintaining a resilient pharmaceutical supply chain in a volatile market.

Far from being mere regulatory hurdles, internal and external Good Manufacturing Practice assessments serve as vital catalysts for institutional growth and the pursuit of operational perfection in pharmaceutical production.

The transition from manual quality assurance to integrated digital platforms is redefining how pharmaceutical and medical device companies maintain regulatory readiness and operational agility.

Ensuring the accuracy and reliability of information is the lifeblood of biotechnology production, where even minor discrepancies in digital or physical records can compromise product safety and regulatory standing.

Konica Minolta Healthcare Americas and deepc have formed a partnership to integrate AI directly into radiology workflows. The collaboration is intended to help hospitals and...

Medtronic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go™ app, enabling the launch of the MiniMed Go Smart MDI...