Authors:

Jerry Chapman

Senior GMP Quality Expert, Redica Systems

Mark Agostino

Business Development, Novo Nordisk

Areas examined in this report:

  • An interview with Redica Systems GMP Medical Device Expert Mark Agostino
  • Information on the EU MDR and its implications for combination products
  • Takeaways from a Redica Systems webinar on smart combination products
  • A review of recent FDA guidances and regulations affecting combination products