Tenders Are Invited For Market Dialogue Invitation: Mdr Ja Iso13485 Quality Management System Consulting Services

Note! This Is Not A Pre-Announcement, A Procurement Notice Or A Request For Tender, But An Invitation To Market Dialogue For Potential Bidders Interested In Procurement. The Procurement Unit (Oy Apotti Ab) Needs Mdr And Iso13485 Quality Management System Consulting Service To Support Its Operations. The Procurement Entitys Goal In This Procurement Is To Acquire One Service Provider That Is Capable Of Providing The Procurement Entity With Comprehensive And High-Quality Services It Needs. The Provider Of The Consulting Service Is Required To Have Special Knowledge And Experience With Software Classified As Medical Devices And Their Special Features From The Perspective Of Quality Management And The Application Of Mdr Legislation. Competence Is Required In Life Cycle Management Of Software Products And Risk Management Of Medical Devices And The Related Standards En 62304 And Iso 14971. Competence And Experience In Patient Information Systems And Clinical Decision Support Systems Are Considered An Advantage. The Scope Of The Procurement And The Special Expertise Required From The Supplier Are Specified In More Detail In The Tender Request Material That Is Being Prepared. Length, Scope And Language Of The Service Procurement Procurement Unit Is About To Acquire Services Initially For A 4-Year Contract Period. The Procurement Unit Anticipates That The Need For The Service Will Exceed The European Unions Threshold Value For A Calculated Period Of 48 Months, In Accordance With The Regulation On The Anticipated Total Value Of The Procurement Act (1397/2016). The Language Of The Procurement Units Customer Interface And Organization Is Finnish, And The Service Is Therefore Procured In Finnish. If Necessary, The Supplier Must Also Be Able To Deliver The Service In English. The Procurement Unit Does Not Commit To Any Order Quantities, But Places The Orders During The Contract Period According To The Current Need. The Contract Supplier Does Not Get Exclusive Rights To The Services According To The Description Of The Procurement Object, But The Procurement Unit Can, At Its Discretion And Depending On The Situation, Also Use Other Suppliers To Produce The Service Or Implement The Service As Its Own Work. The Service Is Based On Separate Assignments During The Contract Period In Accordance With The Current Needs Of The Procurement Unit. The Goal Of The Market Dialogue Is To Map The Market And Initiate An Open Interaction Process Between The Procuring Entity And Potential Bidders And To Review Views And Proposed Solutions For Tendering Procurement That Meets The Requirements Of The Procuring Entity. The Market Dialogue Is Carried Out In Finnish And Mainly Or Entirely As A Written Dialogue. Request For Tender Documents Will Be Sent To Those Who Have Registered For Comment (Contains Specific Questions About Certain Points) And Possibly Discussion Sessions With Suppliers Will Be Arranged. Any Answers Will Be Treated Confidentially And Will Only Be Used For Procurement Preparation. According To The Current Non-Binding Estimate, The Actual Procurement Procedure Will Be Carried Out As An Open Procedure. Bids Will Not Be Given To This Call For Market Dialogue, But A Willingness To Participate In The Procurement Dialogue Will Be Indicated. Participation In The Market Dialogue Does Not Obligate The Participant Or The Procurement Unit To Anything And Is Not A Prerequisite For The Actual Tender Participation. Participating In The Market Dialogue Does Not Affect The Bidders Position In The Possible Bidding Process. The Comments Received In The Market Dialogue Can Be Used To Prepare The Procurement Documents For The Future Acquisition. All The Material Presented In The Market Dialogue And The Discussions Held During It Are Preliminary And Do Not Bind The Procuring Entity Or The Bidder. The Procuring Entity Does Not Undertake To Carry Out The Procurement Specified In The Market Dialogue. Participants In The Market Dialogue Are Not Compensated For Their Participation. (Note At Least One E-Mail Address For Sending The Material) With This Information Request. Registrations Are Not Accepted In Any Other Way.