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

Duration: 3 hours
13.06.2024, 03:00 - 06:00 PM Central Europe Summer Time, 09:00 - 12:00AM US Eastern Standard Time

Speaker: Paige Sutton-Smith

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 FDA after implementation


Training content:

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


Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment