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Tagged iso 13485

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iso 13485

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan to harmonize its current good manufacturing practice requirements applicable to medical device quality systems with internati... Read More...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

New Handbook Helps Medical Devices Sector Improve its Quality Management System

New Handbook Helps Medical Devices Sector Improve its Quality Management System

ISO Publishes Revised Medical Device Quality Management Standard

After nearly four years of work, the International Organization for Standardization (ISO) has published an updated version of its standard for quality management systems used by medical device manufacturers. ... Read More...

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