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
- 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?