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Three Tips for Adding Flexibility to Your Medtech Manufacturing Supply Chain

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Image: National Cancer Institute

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Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.

How to Comply with HIPAA and EU GDPR in Medical Device Studies

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Photo by Jair Lázaro on Unsplash

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Tiny Magnetic Beads Could Help to Quickly Detect Pathogens

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Image courtesy of the researchers
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Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination.

New NIST Measurements Aim to Advance Portable MRI Technology

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Credit: R. Jacobson/NIST
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Magnetic resonance imaging (MRI) machines can

Improving Safety with a Computerized Maintenance Management System

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In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements.

What FDA QSR and ISO 13485 Harmonization Means

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Photo by Piron Guillaume on Unsplash

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On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

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Credit: National Cancer Institute on Unsplash

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Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

How to Improve Employee Uptime

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A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime.

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.

Frontline Workers Gain Remote Work Benefits in Tight Labor Market

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Credit: National Cancer Institute on Unsplash

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The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth.

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