Tenders Are Invited For Information Request: Medical Device Register

We Are Applying For A Medical Device Registry System For The North Karelia Welfare Region (Siun Sote) For Long-Term Use, Which Supports Legal Device Registration And Enables The Management Of Device Data Throughout The Entire Life Cycle. We Are Looking For A Ready-Made Solution That Offers A Clear Data Structure, Efficient Search Functions And Works In Modern Browser And Operating Environments. The System Must Support Individual-Level Inventory And Registration And Enable The Management Of The Devices Life Cycle From Acquisition To Disposal, Including The Planning Of Maintenance, Inspections And Periodic Services, Implementation Monitoring And Documentation. The Solution Must Provide Capabilities For Processing Risk Classifications And Safety Data, And Take Care Of Data Verification, Restoration And Auditing Of Changes. Information Security And Data Protection Must Meet The Requirements Of Siu Sote, Support Ad-Based User Management And Role-Based Access Rights, And Be Based On Recognized Security Standards. The System Must Also Work Smoothly In Mobile Use, So That Devices Can Be Registered And Maintenance Procedures Recorded On Site. The System Must Fit Into Siu Sotes Overall Architecture By Utilizing Existing Api Interfaces And Data Models Without The Need For New Integration Development. Necessary Integrations Include Financial Management Systems, Fluke Biomedical Equipment Measurement Results And Quality Portal.