Training: QMSR Transition — Preparing for FDA ISO 13485 Harmonization in the EU

by | May 7, 2024 | Upcoming Trainings

Training Objectives

  • Understand what has changed from QSR to QMSR
  • Plan how to update your QMS and TD in preparation for the change
  • What to expect from the FDA after implementation

Training Content

  • Review of the QMSR Final Rule
    • What has changed?
    • What is the same?
    • Impact on Inspections
  • Planning QMS Updates
  • Planning TD Updates
  • Implementation Timeline

Training Format

  • Presentation with interactive discussions
  • Exercises during the training
  • End-of-training assessment (participants will receive a training certificate)

Who Should Attend

  • Quality and Regulatory professionals
  • R&D, Engineering, and Design and Development professionals
  • Internal auditors


EUR 355 including course material and certificate