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The Hidden Cost of a Fragmented QMS in Life Sciences

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Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden.

Building a Strong EQMS Foundation

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When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality.

Lessons From GAMP 5

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Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms.

Stress: A Productivity Killer Hiding in Plain Sight

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At Ramirez & Co., a midsize business with decades of wins, leadership thought its biggest challenges were competitors, technology, and the market. Close, but no cigar.

Preparing Your Quality System for AI-Enabled Asset Management

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What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

What Is an FDA Auditor Looking For?

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Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam.

AI ‘Co-Pilot’ Can Reduce Prescription Errors That Put Patients at Risk

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Take two aspirin and call me in the morning: If only prescribing medications were as simple as that.

Wearable, Implantable, and Ingestible Medical Devices

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NIST researcher Kamran Sayrafian developed a computational model of the lungs with different levels of excess fluid. The long-term goal is to develop a device that could alert the patient or medical provider when it detects pulmonary edema in the user’s lungs. 

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A few years ago, I heard on the news that many people were being hospitalized with a condition of excess fluid in the lungs, called pulmonary edema.

University of Perugia Validates New Dental 3D-Printing Materials

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A student at the University of Perugia 3D scanning an implant with Artec Micro II.

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The dental industry is seeing a surge in 3D printing, with the technology enabling a growing number of dentists to rapidly create custom implants in clinics around the world.

Marked for Life

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Lasers enable safe, scratch-resistant marking that’s more durable than ever.

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In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance.

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