Key market opportunities include enhancing regulatory compliance for medical devices through process validation. Understanding quality management ties, FDA/EU/UK guidelines, and GAMP standards grants ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ValGenesis Smart GxP™ platform, at BioProcessing Summit Europe ...