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Why a QM Manual is Key for High-Quality Standards
A Quality Management Manual (QM manual) is a central document in any manufacturer‘s Qu
Aug 02, 2024
# ISO 13485
# CE marking
# MDSAP
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Understanding the Classification of Medical Devices under EU MDR
Classification of medical devices is fundamental to defining their regulatory pathway; c
Jul 26, 2024
# CE marking
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Efficient Supplier Management for Medical Devices Manufacturers
One of the most crucial aspects in building a ISO 13485 compliant quality management sys
Jul 19, 2024
# ISO 13485
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Unlocking Innovation in Healthcare: The Critical Role of Software as a Medical Device (SaMD)
In an ever-changing healthcare landscape, innovation is critical. Software as a Medical
Jul 12, 2024
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Revolutionizing Healthcare: The Impact of Machine Learning-Enabled Medical Devices now and in the future
The integration of machine learning (ML) into medical devices is transforming the health
Jul 05, 2024
# Health care certifications
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Introducing Climate Management: An example from Germany
At its headquarters in Eislingen in the German region of Swabia, the chemical company Zeller + Gmeli
Jul 01, 2024
# Climate Management
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