Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR).
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR).
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.
Photo by National Cancer Institute on Unsplash
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable.
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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.
In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders.
Image: National Cancer Institute
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.
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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.
Magnetic resonance imaging (MRI) machines can
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.
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