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Improving Safety with a Computerized Maintenance Management System

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In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements.

What Is Risk Analytics?

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Risk analytics is a vital component of risk management that uses statistical models, data analysis, and predictive modeling techniques to assess, quantify, and mitigate risks in various domains.

Measuring Up: Kibble Dynamic Force Reference

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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

What FDA QSR and ISO 13485 Harmonization Means

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Photo by Piron Guillaume on Unsplash

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

Stop Going It Alone

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Photo by Thomas Bonometti on Unsplash
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History is filled with tales of courageous and decisive heroes. Individuals like Julius Caesar and Winston Churchill, for example, have led from the front to guide people through adversity and achieve ultimate success.

First Article Inspections: What Engineers Need to Know

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Photo by Gavin Allanwood on Unsplash

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

Managing SOPs With the QMS

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Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.

Making the Business Case for a New QMS Solution

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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.

Five Necessary Steps to Maintain a Reliable CAPA Process

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Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S.

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

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Credit: National Cancer Institute on Unsplash

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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).

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