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EU MDR & IVDR Compliance: Tales from the Trenches

Kim Walker (Independent Global Regulatory Affairs, Quality Assurance, and Clinical Affairs Consultant , Kim Walker Consulting)

Location: 210D

Date: Tuesday, February 11

Time: 1:15pm - 2:00pm

Track: MD&M Conference: Keeping Up & Staying Compliant with Global & FDA Regulations

Vault Recording: TBD

The impending deadlines for the EU MDR and IVDR are causing manufacturers to reassess whether marketing their devices in the EU is practical. This session will review the key compliance challenges for both the MDR and IVDR and how some manufacturers have tackled the transition process.

Topics covered include:

  • A look at the key regulatory and quality system changes required by the MDR and IVDR
  • Best practices for compliance
  • How to destress the EU MDR and IVDR compliance process by applying practical project management tools

Presentation File

Tues_210D_115pm_Walker_ANA2020_EUMDRIVDRComplianceTales_Walker.pdf