Request For Information: Lifecycle Management Solution For Medical Devices

The Pirkanmaa Welfare Area Is Planning To Reform Its Solution For Life Cycle Management Of Medical Devices. The Goal Of This First-Stage Information Request Is To Map The Information Systems On The Market That Support The Legal Lifecycle Management Of Medical Devices And The Medical Device Service. The System Must Meet All The Requirements Of Eu And National Legislation And Contain A Comprehensive Medical Device Register, Where All Core Device Information, Location And Responsible Unit Information, Commissioning Inspections, Periodic Inspections, Maintenance And Repair History, And Removal Process Information Can Be Maintained Up To Date. The Register Should Enable Document Management And Provide Auditable, Traceable Data Changes. With The Help Of Internal And External Audits, The System Can Be Used To Demonstrate The Traceability Of Medical Devices And Compliance With The Organizations Regulations. The System Must Support The Entire Life Cycle Of The Device, From Acquisition To Commissioning, Maintenance And Removal, And Offer Extensive Reporting And Analytics Functions To Support Decision-Making. For Financial Management, The System Must Enable E.G. Billing And Cost Data Monitoring And Lifecycle Cost Management. Functionality For Maintenance Planning, Scheduling And Service Request Management Is Needed For Service And Maintenance Operations. Access Rights Management Must Be Based On A Role-Based Model And Support Strong Identification, Two-Step Identification And Single Sign-On. All User Activities Must Be Logged. The System Must Also Support Integrations With Financial Administration, Service Request Systems And Other Necessary External Services. As Part Of The Discussion Regarding The Planning Of The Reform, The Pirkanmaa Welfare Area Is Interested In Hearing About The Possibilities Of Using Artificial Intelligence And The Possible Added Value For Such A System. With This Request For Information, The Pirkanmaa Welfare Area Starts A Market Dialogue, The Goal Of Which Is To Map The Market Supply Of Systems According To The Description Above. The Dialogue Promotes The Planning Of A Possible Future Acquisition. We Invite Suppliers Interested In The Topic To A Market Dialogue, In The First Stage Of Which We Ask You To Familiarize Yourself With This Request For Information And Its Appendix. In The Next Step, Suppliers Can Be Asked To Present Their Solution At Demo Events, Which Are Planned To Be Organized In February-March 2026. This Request For Information Is Not A Request For Tender, And Does Not Oblige The Pirkanmaa Welfare Area To Purchase. The Procedure And Schedule Information That May Be Presented In The Request For Information Has Been Provided As A Preliminary And Non-Binding Information. The Market Dialogue Invitation Does Not Bind The Respondent (System Supplier) To Possible Participation In A Subsequent Tender, And Responding To It Is Not A Prerequisite For Participating In The Actual Tender That May Be Carried Out Later. The Answers Given To The Request For Information Are Not Public And Are Only Used To Support Procurement Planning. However, We Ask You To Mark Trade Secret In The File Name Of Documents Containing Trade Secrets And At The Beginning Of The Document, If The Document Contains Trade Secrets.