Validant Case Study

Preparing for EU MDR/IVDR Compliance

Challenge

Complying with new EU MDR & EU IVDR laws requires significant changes in clinical evaluation, risk management, general safety and performance requirements (GSPR), supplier/economic operator control, labelling, post-market surveillance, vigilance, and more.

Solution

Validant has helped clients at all stages and sizes to implement a sustainable approach to EU MDR/IVDR compliance by:

  • Providing training for leadership and targeted business units
  • Conducting comprehensive gap assessments
  • Performing phased implementation including project management, process/procedure updates, template creation and record remediation
Outcome
  • Determined best practices
    for implementation and sustainability,     leveraging experience from working with multiple Notified Bodies.
  • Ensured client readiness for Notified Body Conformance Assessments and continued distribution of products.
  • Empowered teams with skills to uphold compliance long-term.

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