Procurement of a robot-assisted system for orthopedics

The subject of the procurement is the rental service of a robot-assisted system for orthopedic surgery, with associated equipment, instruments, and service support. The procedure is carried out with the aim of concluding a framework agreement for a period of 4 years, based on which individual one-year public procurement contracts will be concluded. The offered system must be fully compliant with the technical specifications, functional, and ready for clinical use. The offer must include at least: • installation and commissioning of the system, • provision of necessary instruments and consumables for the system's operation, • the system must be fully functional for performing partial knee replacement surgery. The bidder is obliged to ensure that all necessary software modules, licenses, and functionalities for the specified type of procedure are included in the offered price, without additional costs and without usage restrictions throughout the entire contract period, • the service package during the rental period includes updating the software to the latest available version at no extra charge, providing all necessary service and technical documentation, and resolving technical issues with expert assistance from authorized technicians. It also includes the development and implementation of a regular and extraordinary maintenance plan, provision of spare parts necessary for optimal system functioning, and coverage of transport and technician costs. The bidder must ensure a technician response within 24 to 48 hours from the initial contact, ensuring continuous technical support and system functionality with minimal interruptions throughout the entire contract period. All offered equipment must be fully compliant with the bill of quantities and prescribed technical specifications, as well as all other conditions prescribed by this procurement documentation. Bidders are obliged to offer fully functional, new, unused, and undamaged equipment, with the offered price including all costs, including, but not limited to, delivery, transport, assembly, installation, testing, and commissioning, staff training for proper operation and use at the Contracting Authority's premises, as well as all service package costs during the rental period. The service package includes regular and extraordinary maintenance, software updates, provision of necessary spare parts and consumables, technical support, and all other related costs necessary for the smooth and continuous functioning of the system throughout the entire rental period. The rented item must be fully compliant with the applicable regulations of the Republic of Croatia and the European Union governing healthcare and medical devices, including, but not limited to, the Health Protection Act, the Medical Devices Act, Regulation (EU) 2017/745 on medical devices (MDR), and all related bylaws and technical standards, throughout the entire period of use. Note: Solely for capacity planning and work organization, the Contracting Authority estimates that the system will be used for approximately 150 procedures annually. This information is for guidance purposes only and serves solely as a rough estimate of the expected scope of use, without obligating the Contracting Authority to perform the stated number of procedures. The actual number of procedures may deviate from the stated estimate, depending on the Contracting Authority's needs.