Your MDR and IVDr partner to CE registration - Your partner for FDA submissions - We deliver excellence

Regulatory Affairs

MARACA International can manage part of or your complete regulatory department activities.

This includes the development of or help with the development of:

  • Regulatory strategy plan
  • Regulatory guidances plan
  • Regulatory literature review
  • Regulatory design input
  • Regulatory Performance evaluation plan
  • Regulatory Performance evaluation report
  • Essential requirements document
  • STED Dossier
  • Submission package with FDA
  • Submission package with notified body
  • Communication with FDA and other competent authorities
  • Communication with notified body
  • Registration of manufacturer with FDA and EU competent authorities
  • Registration of products with FDA and EU competent authorities
  • UDI development for products and manufacturer
  • MDR reporting to competent authorities
  • On-market surveillance of product
  • On-market vigilance of product

With more than 20 years’ experience with these activities, we can provide you with unique service excellence. More detailed information and making a proposal?