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 The 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. The Service Concerns The Certification Of Medical Device And Certification Of The Quality Management System Based On The Iso 13485: 2016 Standard Completed By The Issue Of A Separate Certificate In Polish And English. Included Scope Of The Iso 13485: 2016 Certificate Physiological With Software Supporting Diagnostic And Therapeutic Decisions, As Well As Active Medical Devices That Are Software Supporting Diagnostic And Therapeutic Decisions • In English: Design And Development, Manufacture, Maintenance, Service And Placing On The Market Of Active Medical Devices Used In The Monitoring Of Physiological Parameters Together With Diagnostic And Therapeutic Decision Support Software, And Active Medical Devices That Are Diagnostic And Therapeutic Decision Decision Support Software.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 Mdr, Including Clinical Assessment Documentation. 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 Mdra Guidelines) Assessment Of The Technical Documentation Of The Product Created Based On The Guidelines From Annexes Ii And Iii Mdr, Including Clinical Assessment Documentation. The Setting Description Of The Subject Of The Contract Is Included In Annex 1 To Swz.

Refer document

FileName	File Description
Global Tender Document	Tender Notice