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Implementing ISO 13485

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Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices.

Quality Manufacturing Requires Data for Efficient Vendor Management

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Manufacturers face constant challenges of rising expectations as customers and regulators demand better quality and greater traceability throughout the supply chain.

Field of Daisies

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A daisy rising from my brick walkway reminded me this morning, that even in the worst environment, there is a chance for growth. But this kind of individual heroism does not portend success for lean transformation.

The Pickleball Serve and Theories of Variability

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Credit: Michael & Sherry Martin

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Pickleball is arguably the fastest-growing sport in the United States, especially among baby-boomer retirees.

How To Transport Delicate Goods Safely With Fleet Management Systems

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Transporting cargo over long distances has always been a logistical nightmare, but when the goods are of a delicate nature, the whole operation becomes significantly more challenging.

Cost, Quality, Schedule: How 3D Printing Helps Production Engineers Get the Job Done

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On factory floors all over the world, 3D printing has quietly moved from a prototyping novelty to an essential tool.

Wake-Up Call: Class I Manufacturers, Get an Early Start on EU MDR Compliance

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On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect.

‘Any Theory Is Correct in Its Own World...

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As statistical methods become more embedded in everyday organizational quality improvement efforts, I find that a key concept is often woefully misunderstood, if it is even taught at all. W.

Aerospace Acumen: How Do They Do It?

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The aerospace industry is known for manufacturing parts with critical dimensions and tight tolerances, all of which must undergo demanding inspections.

Why Future Jobs Will Require Data Analytics Skills

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From a lone statistician toiling over narrowly defined problems for the marketing department, to a C-level executive overseeing a mission-critical area impacting every function of the company, the meaning of “data and analytics professional” has changed a lot in rece

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