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quality management

FDA Amends Quality System Regulations for Medical Devices

The U.S. Food and Drug Administration (FDA) has amended its quality system regulations applicable to the manufacture of medical devices.

EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards...

Are You Ready for the MDSAP?

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP).

ISO Publishes Revised Medical Device Quality Management Standard

After nearly four years of work, the International Organization for Standardization (ISO) has published...

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