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Key to Surviving a QMSR Inspection?  Risk, Baby, Risk

by Brian | Jul 10, 2026 | New/Updated Regulation

July, 2026  Silver Spring, MD USA.  Back in 2008, at the Republican National Convention, then Maryland Lieutenant Governor Michael Steele coined the phrase “Drill, Baby, Drill” to promote U.S. energy independence by encouraging increased domestic oil and gas...

MDSAP Audit Approach Updates May Impact Your Next Audit

by Brian | Feb 26, 2026 | Guidance Documents, New/Updated Regulation

26 Feb 2026  Silver Spring, MD.  The USFDA, as the Regulatory Authority Council (RAC) Chair and Secretariat for the Medical Device Single Audit Program (MDSAP) for 2026 and 2027, started the audit year off with a bang, updating the MDSAP Audit Approach, used...

FDA Implements QMSR for your next Medical Device Inspection

by Brian | Feb 16, 2026 | New/Updated Regulation

February, 2026: Silver Spring, MD USA.  On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers...

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Recent Posts

  • Key to Surviving a QMSR Inspection?  Risk, Baby, Risk
  • MDSAP Audit Approach Updates May Impact Your Next Audit
  • FDA Implements QMSR for your next Medical Device Inspection

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Recent Posts

  • Key to Surviving a QMSR Inspection?  Risk, Baby, Risk
  • MDSAP Audit Approach Updates May Impact Your Next Audit
  • FDA Implements QMSR for your next Medical Device Inspection
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