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FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance

July 27, 2022December 22, 2022 stevensevert2

FDA Releases New Draft Guidance for Remote Regulatory Assessments

July 1, 2022July 27, 2022 stevensevert2

FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing

March 2, 2022December 22, 2022 stevensevert2

The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485

February 23, 2022December 22, 2022 stevensevert2

After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485

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Is My Product a Medical Device?