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August 23, 2024
WARNING LETTER Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 685606 Globus Medical, Inc. Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403 Dates: February 15, 2024, through March 7, 2024 Inspection Issue(s): These violations include, but are not limited to, the...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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