MARACA-International is an international consulting company providing executive-level services for Medical, Regulatory, Clinical Affairs and Quality to Pharma, Medical Device, IVD companies and to clinical laboratories in Europe, the US and other countries. A main focus is services around the development of Companion Diagnostics, management of the clinical registration studies and their registrations in Europe, the US and the other countries. Services include development of quality systems for IVDs and medical devices, development of design control files, risk management, medical vigilance, on-market surveillance, clinical study management and regulatory submissions to FDA or under the new European IVDr or MDr, education & training, product registrations, auditing of quality systems, design history files and design master files.