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Best Practices for an Effective Medical-Device Design Transfer Process

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If you’re looking for information on medical-device design controls and product development, you can find a practically endless number of articles, videos, and podcasts with a few quick online searches.

Lean Lessons From Covid

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You may recognize the following quote from Friedrich Nietzsche, or more recently from Kelly Clarkson: “What doesn’t kill you makes you stronger.” I’ve thought about this often during the last 22 months in context of the horrible pandemic and, more parochially, in rel

Happy 40th, QD!

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It’s hard to fathom that Quality Digest, a little Northern California media company respected by all and beloved by many, turned 40 in November 2021. For a human being, 40 may be the new 30, but it’s still just creeping up on middle age.

After a Global Pandemic, Are Fully Remote QMS Audits Truly Effective?

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Although ISO 19011—“Guidelines for auditing management systems” has included language about remote quality management system (QMS) auditing since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns t

Digital-First Supply Chains Are Critical

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It’s common to hear about how the Covid-19 pandemic has disrupted supply chain operations. Supply chain leaders are navigating one of the most difficult periods in recent history, and it’s impossible to foretell an end to global disruptions.

Achieving Better Medtech Outcomes With Proactive Post-Market Surveillance

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In the medtech space, all roads lead to quality. Unlike pharma, which looks at safety and quality separately, all of the information around risk and vigilance to inform product improvement will be housed within a medtech company’s quality management system (QMS).

Using NVH System Prediction for Early Design and Virtual Prototyping

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Siemens Digital Industries Software introduces System NVH Prediction, a new Simcenter software application.

Creativity May Suffer When Mature Projects Change Hands

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Justin Berg has watched Back to the Future at least 25 times. Same with the DVD special features—the voiceovers and backstory and interviews.

What E-Commerce Will Look Like in 2022

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Getting your product into customers’ hands is often an undervalued—and under-engineered—part of your organization’s value chain.

It’s Not ‘The Great Resignation.’ It’s Actually ‘The Great Recognition.’

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Some are calling it, “The Great Resignation.” Others are calling it “

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