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Linking Design Controls and Risk Management in the QMS

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Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

Embracing Net Zero

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Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic, social, and health advantages.

Five Benefits of Supply Chain Quality Control Software

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Supply chain quality control is a demanding job.

How to Develop a Risk-Based Approach to Supplier Management

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Photo by National Cancer Institute on Unsplash

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The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.

Finally: Quality Tools Are Becoming More User-Friendly

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Photo by Greg Rosenke on Unsplash
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‘I have a cellphone that doesn’t behave like a phone: It behaves like a computer that makes calls. Computers are becoming an integral part of daily life.

Embracing AI-Driven Technology to Augment Quality and Regulatory Activities

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Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country.

Studying Food Safety Through Measurement

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The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.

Finally, Women Are Being Represented in Vehicle Testing

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Despite rigorous vehicle safety testing, current evaluations fail to adequately protect women in the case of an accident.

Understanding ISO 14971 Medical Device Risk Management

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Photo by Jair Lázaro on Unsplash

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Medical device companies must have established risk management processes that comply with ISO 14971.

How to Build Resilience Instead of Chasing Zero Errors

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"Making the Connection" Credit: Andrew Barclay

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Wildland firefighters. Air traffic controllers. Flight deck crews of aircraft carriers. Operators of nuclear power plants and the national bulk electric grid. These are among the safest and most reliable work teams in the world.

Pagination

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