Mediteq Forum Digital – What happens on the US market?

Mediteq Forum

we are excited to again welcome Michelle Lott from Lean RAQA as guest.

We have had the privilege to listen to Michelles knowledge and experience on

US medical device regulations before.

In this session she will share insights and information on recent changes and possible impacts.

Some key points from the presentation:

• How are FDA submissions affected by layoffs?
• Other effects of layoffs and leadership changes
• “US first” strategy – still valid?
• Transition from QSR to QMSR – impact on EU-based manufacturers:
  Since ISO 13485 is already established in the EU, what practical implications does the shift to QMSR have for us?
• What needs to be updated in our Quality Management System (QMS)?
  We will review which updates may be necessary to maintain compliance when exporting to the U.S. under the new QMSR framework.

Date: 3^rd September 2025, from 16.00 – 18.00

Digital: Zoom link will be available for participants

Sign up: Link

Program: Link