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Ben McGovern

Ben's passion for life sciences emanates from the notion that he can support organizations in their quest to create life-changing therapies and devices. He has over 10 years of experience in Mentoring and Supporting Compliance Leadership, Inspection Readiness, & Audits and Gap Assessments.
QSR Transition to QMSR
Compliance ► December 13, 2023

QSR Transition to QMSR

In early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...

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Recent Posts

  • Printing Electronic Data Doesn’t Solve Data Integrity Issues—Here’s Why
  • Why the FDA’s LDT Rule Was Necessary—Even If the Court Disagreed
  • International Women’s Day – This One’s for the Girls!
  • From Team Member to Team Leader: Navigating the Challenges of Management
  • Training Effectiveness vs. Training Competence: Understanding the Nuances

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