REGULATORY ASSISTANCE Ministry of Health and Ethics Committees submission Safety Reporting A dedicated start-up unit is in place with full knowledge of regulations and local procedures. MCR can manage regulatory submissions and negotiate financial contracts on Sponsor's behalf. MCR has esperience in notification of clinical investigations with medical devices to the Ministry of Health. MCR can support the sponsor for reporting of SUSARS to Health Authority and Ethis Committee as well as for distributing CIOMS to the investigators. << BACK