Regional Regulatory Update Of US &EU

Regulatory update actively monitors and analyses regulatory changes in countries worldwide, helping them to ensure compliance on an on-going basis and enabling them to easily roll out regulatory reporting operations into multiple branches, as well as reducing total cost of ownership and maintenance once the system is fully configured.

  • US FDA Regulation Changes: When to Submit a 510(k) for a Change to an Existing Device
  • EU IVDR: Classifications/Performance Evaluation
  • EU MDR and IVDR: Postmarket Expectations Including PMCF
  • US Regulatory Landscape for Laboratory Developed Tests (LDTs)
  • EU MDR and IVDR: International Impact of the New EU Regulations

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Regional Regulatory Update Of US &EU Conference Speakers