Finlandia - Apparecchiature mediche, prodotti farmaceutici e per la cura personale - Richiesta di informazioni: HUS 364-2026 Sistemi di impianti osteointegrati

Helsinki University Hospital (HUS) and HUS Procurement is currently exploring solutions related to osseointegrated implant systems for patients with upper and/or lower limb loss. The purpose of this Request for Information (RFI) is to obtain information on products currently available on the market, their technical and clinical characteristics, implementation requirements, and supplier capabilities. The information obtained through this RFI will be used to increase HUS's understanding of the market and to support the planning of a potential future procurement process. SUBJECT OF THE MARKET DIALOGIA AND THE SOLUTION MAY INCLUDE: Intramedullary osseointegrated implants. Implant fixation components and connecting elements. Transcutaneous or equivalent prosthetic attachment systems. Surgical instruments and implantation equipment. Accessories and supporting products required for clinical use. Digital solutions, monitoring tools, or software related to the implant system, where applicable. Training, clinical support, and implementation services. The implant system should be intended to provide direct skeletal attachment of an external prosthesis as an alternative to conventional socket-based prosthetic solutions. SUPPLIERS ARE INVITATED TO PROVIDE INFORMATION ON THE FOLLOWING TOPICS: Company Information; name and contact details. Experience with osseointegrated implant systems. Product Information; name and commercial designation. Intended use and clinical indications. Description of the implant system and its main components. Available implant sizes, versions, and configurations. Materials used in the implant and connection components. Compatibility with external prosthetic systems. Clinical Evidence, available clinical studies and scientific publications, survival rates, complication rates, and long-term outcomes. References from hospitals currently using the system. Regulatory Information with certifications; CE marking status, Compliance with applicable European Union regulations. Surgical training requirements. Training programs for surgeons and clinical staff. Technical support and customer service. Guidance for patient follow-up and rehabilitation. Logistics and Commercial Information Product availability within Europe. Typical lead times. Product lifecycle expectations. Availability of spare parts and accessories. Information on maintenance, upgrades, and product development plans. MARKET DIALOGUE MEETING HUS procurement may invite selected suppliers to participate in a market dialogue meeting. The purpose of the discussions is to obtain further information regarding available solutions and market capabilities. Meetings may be arranged remotely via Microsoft Teams. DISCLAIMER This Request for Information is a preliminary market consultation and information-gathering exercise only. Participation in this RFI or any subsequent market dialogue does not create any obligation for HUS to initiate a procurement procedure, award a contract, or compensate suppliers for any costs incurred in preparing responses or participating in discussions. Neither the request for information nor its replies are binding on either party. Responding to a request for information does not affect the position of the tenderer in the forthcoming tender. The information provided by suppliers may be used solely for planning and preparing a potential future procurement process in accordance with applicable procurement legislation. SUBMISSION INSTRUCTIONS Suppliers are requested to submit their responses electronically in English. Responses should include all relevant supporting documentation, including product brochures, technical specifications, clinical evidence, and regulatory documentation where available. Answers should be submitted by 31.08.2026 12:00 GMT+2 at the latest to the email address: kilpailutus.kirurgia@hus.fi. The title or message field of the e-mail should mention: HUS 364-2026 Ortopediset Osseointegroitavat yläraajaimplantit.