Tenders Are Invited For Conducting The Mentalio Medical Device Certification Process In Class Iii In Accordance With Medical Device Regulation (Eu) 2017/745
Tenders Are Invited For Conducting The Mentalio Medical Device Certification Process In Class Iii In Accordance With Medical Device Regulation (Eu) 2017/745
Conducting The Mentalio Medical Device Certification Process In Class Iii In Accordance With Medical Device Regulation (Eu) 2017/745 Commercial Name Of The Product: Mentalio - A System Of Support For Diagnostic And Therapeutic Decisions In The Area Of Mental Health Of Teenagers Based On Artificial Intelligence Algorithms. 1. Formal Assessment Of The Certification Of Class Iii Medical Device According To Medical Devices Regulation (Eu) 2017/745 In Accordance With Annex Ix (Hereinafter Referred To As Mdr). 2. Substantive Assessment Of The Product Technical Documentation According To Md. 3. Assessment Of The Quality Management System For Compliance With Md. 4. Certification Process Of Class Iii Medical Product In The Form Of A Mentalio Medical Device For Compliance With Md. 5. All Technical Documentation For A Medical Device Is In A Mixed Language System: Polish And English. The Whole Process Of Assessing The Compliance Of The Product Is To Be Carried Out In Polish. 6. The Offer Of Notified Institutions As Part Of The Certification Process Of Class Iii Medical Device That Is Ai Software Should Include: A) Assessment Of The Quality Management System Based On The Mdrb Guidelines) Assessment Of The Technical Documentation Of The Product Created Based On The Guidelines From Annexes Ii And Iii Of The Md. Md. Delivery Description Of The Subject Of The Contract Is Included In Annex 1 To Swz.
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