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QMSR and the End of DMR, DHR, and DHF

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The wording is different, sure, but the goal of this record-keeping is the same. Photo by Chang Duong on Unsplash

 

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If you’re a medtech professional who’s been working with the quality system regulation (QSR) in the United States, then you’re probably familiar with the three terms the U.S.

The Focused Docs and the Patient

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Photo by atwena Goodman on Unsplash

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As years roll on, I’m noticing more parts of me breaking down: Teeth, eyes, knees, cardiovascular, stomach—the list keeps getting longer, as does the list of docs I see.

ISO’s New Climate Requirements

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“Did someone say ‘global warming?’” Credit: akahawkeyefan

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The International Accreditation Forum (IAF) and ISO have published a joint communiqué to require organizations to “consider” climate change in the context of ris

The Power of Change Management Tools

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Look through even a few FDA warning letters and you’re likely to find violations related

A Leadership Lesson From <em>Kung Fu Panda</em>

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Photo by Marcus Dietachmair on Unsplash

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You can learn a lot about leadership from Master Oogway in Kung Fu Panda. He emphasizes leading today rather than worrying about yesterday or tomorrow.

How Satisfied Are You With Your Work?

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Photo by Vitaly Gariev on Unsplash

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Be honest: How satisfied are you with your work right now?

Tech-Enabled Healthcare

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Photo by National Cancer Institute on Unsplash

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Health connects each one of us to one another. No matter where we are in the world, who we are, or what we do, the state of our health is a key determinant in our quality of life. Simply put, it’s our most valuable asset.

The Past and Future of the Quality Profession

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Wasted motion adds cost but no value. Henry Ford pointed out that people cannot be paid to walk, and that no job should require anybody to bend over or take more than one step in any direction.

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Although quality management has been around in some form or another for thousands of years—a cover of Joseph Juran’s Quality Handbook depicted Egyptians making very precise measurements for the construction of pyramids—this article will show that quality is

The Importance of the Plan-Do-Check-Act Cycle

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The plan-do-check-act (PDCA) cycle plays a central role in fostering improvement by facilitating a structured and ongoing approach to problem-solving.

Unraveling the Corporate Control Agenda Behind RTO

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In the evolving landscape of workplace dynamics, the trend toward revoking employee flexibility and mandating a return to the office (RTO) is gaining traction among corporations, as evidenced by significant players like Boeing enforcing near-full-week office attendan

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