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


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

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

  • Quality System per ISO 13485
  • Quality System per US 21CFR 820
  • Integration of Quality System requirements from other territories, such as Canada, Australia or China.
  • Quality Manual
  • Design control technical file documentation
  • Risk management process
  • Product labeling and UDI
  • Complaint and CAPA processes
  • Nonconformity process
  • Auditing
  • Supplier management
  • Manufacturing control
  • Distribution control
  • On-market vigilance process
  • On-market surveillance process

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