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How to Improve Biomed Technicians’ Quality of Life

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Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets.

Risk Management in ISO 13485

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In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR).

Validation Life Cycle Management Speeds Auditing, Facilitates Regulatory Inspections

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If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted.

Healthcare Management and ISO 7101

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Photo by National Cancer Institute on Unsplash

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Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable.

How to Structure a Clinical Investigation Report Summary

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Photo by Guillaume Périgois on Unsplash

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If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

Health Systems Need More Insight Into Inventory, Supply Chain

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In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders.

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

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