Belgia – Microscoape cu fluorescenţă – Purchase, delivery and installation of a high-sample throughput and automated quantitative multispectral whole-slide imaging and analysis system

Achiziție, livrare și instalare a unui sistem automatizat de imagistică și analiză multispectrală a lămpilor întregi cu viteză mare de eșantionare și analiză cuprinsă în imagistică

The system shall be capable of performing the following functions:

- Digitalisation of histological and cytological slides, including immunohistochemistry (IHC) and in situ hybridization (ISH) slides, at a minimum resolution of 20x and 40x magnification.

- Generation of high-resolution digital images with a minimum pixel size of 0.23 µm at 40x magnification.

- Automatic detection and quantification of cellular and subcellular structures, including nuclei, cytoplasm, and membranes.

- Automated analysis of immunohistochemical and in situ hybridization markers, including quantification of staining intensity and distribution.

- Integration with laboratory information systems (LIS) and picture archiving and communication systems (PACS) for seamless data exchange and workflow management.

- Compliance with relevant EU regulations and standards, including the Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

- Compliance with relevant EU data protection regulations, including the General Data Protection Regulation (GDPR) (EU) 2016/679.

The system shall be delivered with the following components:

- Imaging hardware, including microscope, camera, and illumination system.

- Software for image acquisition, processing, and analysis.

- Calibration slides and reagents for quality control.

- User manuals and training materials.

- On-site installation, training, and maintenance services.

The supplier shall provide a warranty of 36 months for the system, including hardware and software components, and shall be responsible for any defects or malfunctions occurring during this period. The supplier shall also provide maintenance and support services for a period of 5 years after the delivery of the system.

The supplier shall ensure that the system is delivered and installed within 6 months after the signing of the contract. The supplier shall also ensure that the system is fully operational and meets all the specified requirements before the acceptance by the contracting authority.

The contracting authority reserves the right to reject any offers that do not comply with the specified requirements or that are incomplete or unclear. The contracting authority also reserves the right to negotiate with the suppliers and to award the contract to the supplier that offers the best value for money.

The contracting authority shall evaluate the offers based on the following criteria:

- Technical compliance with the specified requirements (40%).

- Price (40%).

- Quality of the proposed solution (10%).

- Experience and qualifications of the supplier (10%).

The contracting authority shall award the contract to the supplier that offers the best value for money, taking into account the evaluation criteria and the total cost of ownership.

The contracting authority shall publish the results of the procurement procedure on the TED eTendering platform and the official website of the contracting authority.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU public procurement directives and regulations, including Directive 2014/24/EU on public procurement and Directive 2014/25/EU on procurement by entities operating in the water, energy, transport and postal services sectors.

The contracting authority shall ensure that the procurement procedure is transparent, fair, and non-discriminatory, and that all suppliers have equal opportunities to participate in the procedure.

The contracting authority shall ensure that the procurement procedure is conducted in a timely manner and that the system is delivered and installed within the specified timeframe.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU regulations and standards, including the Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU data protection regulations, including the General Data Protection Regulation (GDPR) (EU) 2016/679.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU regulations and standards, including the Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU data protection regulations, including the General Data Protection Regulation (GDPR) (EU) 2016/679.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU regulations and standards, including the Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU data protection regulations, including the General Data Protection Regulation (GDPR) (EU) 2016/679.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU regulations and standards, including the Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

The contracting authority shall ensure that the procurement procedure is conducted in accordance with the relevant EU data protection regulations, including the General Data Protection Regulation (GDPR) (EU) 2016/679.