Knowledge Bank

Siemens Healthineers opens new €10M R&D centre in Ireland with the official launch of a new Centre of Excellence for Immunoassay Instrument Research and Development...

Siemens Healthineers FDA clearance for PET/MR scanner marks a significant step in advanced hybrid imaging, with the company receiving regulatory approval for its second-generation Biograph...

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.