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Tender Details
- 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: 124221977
- Deadline: 19 Aug 2025
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: 2025/BZP 00368243/01
- Purchaser's Detail :
- 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 algorithms intelligence. The subject of the pollination is to conduct the certification process and supervise the certificate issued. The sensation applies to certification of medical device and certification of the quality management system based on the ISO 13485: 2016 standards ended with the issue of a separate certificate in Polish and English. ACTIVE SCOPE OF THE ISO 13485: 2016 Certificate: In Polish: Design and divorce, production, maintenance, service and placing on the market of active medical devices used in monitoring physiological parameters together with software supporting software to make diagnostic decisions and therapeutic and active medical devices of the supporting software to make diagnostic and therapeutic decisions in English: Design and Development, Manufacture, Maintenance, Service and Placing on the Market of Active Medical Devices used in the...
- Documents :
Purchaser : NIVALIT SP. Z O. O.
Cracow
Email :contact@nivalit.com
URL :https://nivalit.com/
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