quality management

Third-party test labs undergo rigorous ISO 17025 accreditation audits lasting days or weeks. Learn what auditors scrutinize—from equipment calibration to facility layouts—and why accredited labs provide manufacturers with the highest-quality compliance testing and reliable results.

The U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

The Commission of the European Union (EU) has updated its list of harmonized standards...

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP).

After nearly four years of work, the International Organization for Standardization (ISO) has published...