Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets.

As we celebrate the United States’ 250th anniversary this year, NIST experts have been working to preserve our nat

As a significant portion of the experienced manufacturing workforce approaches retirement, companies face the critical threat of losing undocumented tribal knowledge.

For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework.

With Hexagon Manufacturing I

As pharmaceutical manufacturers push toward lower detection limits, tighter impurity thresholds, and faster development cycles, elemental analysis has become a more critical part of quality and compliance.

In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven.

FDA inspectors don’t just check your records. They bring their own thermometer.

Quality Digest recently spoke with David Isaacson, the executive director of portfolio marketing at Octave.

Industrial robots don’t just shape pay today.