Maraca International BVBA Quality

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