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, ...

Jonathan Andrus, co-CEO of CRIO, explains how protocol-driven eSource templates and standardized data capture are improving ...

ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology leader has successfully expanded its use of the ...

Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, ...

This document is a collective assembly of techniques designed to test the quality and accuracy of 100 whole human genome sequences resulting from the $10 Million Archon Genomics X PRIZE (AGXP) ...

A cable-free protocol analyzer and exerciser from Keysight enable PCIe 6.0 protocol and Compute Express Link (CXL) validation. The P5570A analyzer and P5573A exerciser cards operate at up to 64 GT/s ...