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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).

Using Active Listening to Transform Manufacturing Workplace Environments

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While recent economic reports on inflation have signaled positive signs for the future, frontline industry turnover rates remain high.

Stop Going It Alone

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

Six Reasons Hybrid Employees Should Come to the Office

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Hybrid employees don’t hate the office; they hate commuting to it,

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.

How to Become a Strategic Thinker and Move Into Leadership

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Ask any executive what he or she considers the most important skills for team members who aspire to leadership roles, and you will get answers ranging from clear communication to collaboration to adaptability.

What to Do When You Make a Firing Mistake

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Sometimes you fire someone who doesn’t deserve it. Your job as a leader is to admit the mistake and do your best to rectify it properly as soon as possible.

AI-Assisted 3D Printing: Insights on Emerging Trends and Technologies

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Additive manufacturing (AM) and AI are two of the most exciting fields in technology today. 3D printing has revolutionized manufacturing and design, allowing for the creation of complex objects with ease.

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

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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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