EU MDR Implementation and Organizational Change Management Webinar

As a consequence of the COVID-19 pandemic, the European Commission (EC) accepted a proposal to postpone the EU MDR application date. While the reprieve may be welcome by manufacturers who have delayed implementation or may still be working through their assessments, the extension should not delay the momentum towards full implementation.

While the regulation changes can seem overwhelming, defining a strategy to manage changes across the organization and multiple systems will provide a practical pathway to implementation.

This 20-minute webinar from AssurX provides a high-level perspective on crucial MDR changes and interdependencies across the product lifecycle.

Key focus areas include:

  • Impact of changes in MDR oversight by Notified Bodies
  • Considerations for technology transitions including QMS interaction with other systems
  • Expansion of manufacturer responsibilities
  • Implementing post-market surveillance that supports continuous product evaluation and improvement
  • EU MDR Organizational Change Management Journey Map
  • Solutions that support EU MDR requirements

Download the AssurX EU MDR Solution Brochure

The AssurX EU MDR solution aligns business logic with the most up-to-date MIR template published by the European Commission (EC) and automates the documentation and submission under vigilance guidelines and reporting time frames.

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