In the era of the industrial internet of things (IIoT), assets of both information technology (IT) and operational technology (OT) are becoming more sophisticated—and they both generate and use more data.

I’ve observed that ISO management system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.

Static force, such as the weight of a person standing motionless on a bathroom scale or the force that an office full of equipment exerts on a high-rise floor, can be easily determined using scales, balances, load cells, and the like because static force doesn’t chan

On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

It’s been a long and arduous road, but you’re almost ready for that first production run.

Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a dedicated purchasing department operating under finance’s umbrella.

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be.

Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.