Germany – Detection and analysis apparatus – Procurement of two automated staining and coverslipping machines for the Institute of Pathology at Klinikum Nürnberg

Opportunity description

Delivery, installation, commissioning and instruction for two automated staining and coverslipping machines for the Institute of Pathology at Klinikum Nürnberg Klinikum Nürnberg intends to procure a total of two new automated staining and coverslipping machines for the Institute of Pathology at Campus Nord. The subject of the invitation to tender is the delivery, assembly, commissioning, testing and training for the operational introduction of the two staining and coverslipping machines for the Institute of Pathology at Klinikum Nürnberg, a maximum-care hospital with a university mandate (Paracelsus Medical Private University). The devices will be used for the daily routine diagnostic tasks arising in histology and must be able to handle the current workload of approximately 280,000 slides per year (H&E, PAS and special staining) at Campus Nord. Following the award of the contract, a workflow concept is to be developed jointly by the bidder and the users to ensure the continuous work process with regard to the new devices in the histopathology laboratory. This concept is to describe the practical process for loading, staining, coverslipping, drying, unloading and quality assurance. These are laboratory devices used for the diagnosis of patient samples. For this purpose, the requirements of the current Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC must be fulfilled mandatorily and in full. The Institute of Pathology is accredited by the German Accreditation Body (DAkkS) and currently operates in accordance with DIN EN ISO 15189:2024-08 and DIN EN ISO 17020:2012-07. The prerequisites for compliance with the quality standards of the institute’s internal quality management system, including risk management and performance monitoring, must be in place. The staining and coverslipping machines put out to tender as part of the overall service will be operated in the Institute’s two designated laboratory rooms and must meet the specifications criteria relating to the local conditions. High-performance device systems with high throughput are required for routine H&E staining and special staining, supporting an automated process sequence with integrated drying and reliable further processing of the slides. The slides to be used must be suitable for microscopic diagnostics and for scanning in the digital pathology system to be deployed in the future Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.