Implementing a computerized maintenance management system (CMMS) isn’t just a monetary investment.

If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

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system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.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