It Services: Consulting, Software Development, Internet And Support – Procurement Of The Device Passport System. The Social And Health Services Of The City Of Helsinkis Social, Health And Rescue Department Acquires A Finnish-Language, Digital Browser-Based System For Ensuring And Documenting Expertise In Medical Devices (Regulation (Eu) 2017/745 On Medical Devices) As A Comprehensive Service. The System Will Be Used By Social And Healthcare Professionals Who Use Medical Devices In Their Work, As Well As Their Supervisors. The Estimated Final Number Of Users Is Approx. 7,000. The Number May Differ Substantially From The Estimate. Commissioning Will Take Place During The Years 2024 And 2025. Depending On The Risk Classification (Stm 2023: Safe Use Of Medical Devices – A Guide To Ensuring Device Competence), The Entity Formed By The Training Content And The Competence Certificate, I.E. The Device Passport, Can Be Device- Or Device-Group-Specific. The Content And Execution Method Of The Device Passports Vary According To The Risk Classification. Competence Is Acknowledged As A Self-Assessment Or Completed As A One- Or Multi-Phase Study. Each Device Passport Contains Or Can Be Added To Different Material (For Example, User Manual, Video Links, Exam And Screen Test Taker Material). The Employee Himself Acknowledges All Steps As Completed. In Addition, The Acquired System Must Have Tools Intended For Supervisors To Monitor Equipment Expertise At The Employee And Unit Level, A Senior Management Reporting Tool And A Summary View For Experts. The System Includes The Possibility To Implement Competence Management And Documentation Of Other Areas Than Medical Devices At A Later Stage. In More Detail, The Object Of Procurement And The Requirements Are Described In The Appendices Of The Request For Tender. The Tenders Are Selected On The Basis Of Overall Economic Affordability, So That The Weighting Of The Price Is 60 Points And The Weighting Of The Quality Is 40 Points. (Total 100 Points).
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