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Closed-Loop Traceability for FDA Compliance

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Demonstrating identification and traceability in all quality system processes is a must for medical device companies to

Three Steps to Prepare for Data and AI Leadership

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With big data and artificial intelligence (AI) transforming business, it’s almost certain that every executive will need to leverage these technologies at some point to advance their organization—and their career.

How to Build Medical-Device Usability Testing and Validation Into Your Quality System

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Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

All Hands on Deck for the Circular Economy

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Suddenly, supply chains are in the spotlight.

Remote Work Can Be a Lot Better Than This

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This story was originally published by Knowable Magazine.

Will Digitalization Help Manufacturers Fare Better Post-Covid?

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The ongoing pandemic has pushed many jobs to virtual settings and home-based working environments. In industries outside manufacturing, it can be seen how the pandemic has affected business.

Simple Rules for the Post-Pandemic World

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As soon as South Korea confirmed its first case of Covid-19 on January 20, 2020, the government set in motion a disease control protocol that was to become the envy of other developed

Five Steps to WFH Cybersecurity

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Despite the high ratio of intelligent work-from-home (WFH) business professionals, the current cybersecurity landscape for that work model could best be described as disorganized and dysfunctional.

Applied Root Cause Analysis, Part 2

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Root cause analysis is not a singular way to an answer. It is a conceptual framework for investigating the true reasons behind the events we observe. Many frameworks are available to execute RCA that have been tried and tested by experimenters.

Industry 4.0: Crafting the Future With AI, Robotics, and Automation

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Just like its predecessors, this fourth industrial revolution (dubbed Industry 4.0 in 2011) is all about increasing productivity.

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