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Revision of ISO 9001:2015 to be available in 2025
August 2023: Simple majority in favor of revision. In the vote of the ISO/TC 176 SC2 technical commi
Sep 16, 2024
# Quality Management ISO 9001
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Risk Management in the Medical Device Industry
Risk management is central to the performance and safety of medical devices, and, conseq
Aug 08, 2024
# ISO 13485
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
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# MDSAP- Medical Device Single Audit Program
Understanding the Classification of Medical Devices under EU MDR
Classification of medical devices is fundamental to defining their regulatory pathway; c
Jul 26, 2024
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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
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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