- Country: Poland
- Summary: Conducting the Mentalio Medical Device Certification Process in Class Iii in Accordance with Medical Device Regulation (Eu) 2017/745
- PLT Ref No: 120217544
- Deadline: 10 Jun 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 2025/BZP 00258996/01
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- Description:
- Conducting the Mentalio medical device certification process in class III in accordance with Medical Device Regulation (EU) 2017/745. Trade name for the product: Mentalio support system for diagnostic and therapeutic decisions in the area of mental health of teenagers based on artificial algorithmsintelligence. 1. Formal assessment of the application for certification of class III class Medical Medical Devices Regulation (EU) 2017/745 in accordance with the IX IX (hereinafter referred to as MDR). 2. Substantive assessment of the technical documentation of the product MD. 3. Assessment of the quality management system consistent with MD. 4. ProcessCertificates medical wyb class III in the form of a mentalio medical device consistent with MD. 5. CAA technical documentation for a medical device is in a mixed jicket: Polish and English. The whole process of assessing the compliance of the product would be carried out in Polish. 6. Offer of notified institutionsAs part of the certification process of the III class medical device with AI Winna software: a) assessments of the quality management system based on the MDRB guidelines) assessments of the technical documentation of the product created based on the guidelines from Zakieniki II and III mdd.Pro ...
- Documents:
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CLICK HERE TO LOGINConducting the Mentalio Medical Device Certification Process in Class Iii in Accordance with Medical Device Regulation (Eu) 2017/745 - Poland Tender
The NIVALIT SP. Z O. O., a Government sector organization in Poland, has announced a new tender for Conducting the Mentalio Medical Device Certification Process in Class Iii in Accordance with Medical Device Regulation (Eu) 2017/745. This tender is published on PolandTenders under PLT Ref No: 120217544 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-06-10.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
