Quality system for CE mark

Purpose and goal

The purpose has been to develop a quality system that enables Qlucore to CE mark our upcoming product for cancer diagnostics - Qlucore Diagnostics. The goals of the competence enhancement have been three: 1) To introduce the quality systems required for a CE mark for cancer diagnostics within the framework for the new IVDr regulation. 2) Start building competence within quality 3) Understand how existing development processes need to be developed All three goals have been achieved.

Expected results and effects

We have a quality system in place. It has been implemented both technically with the help of Sharepoint and Docusign and process-wise with a large number of "standard operating procedures", templates and work instructions. The outcome has been very good in relation to the plan.

Planned approach and implementation

The work has been carried out in four sub-blocks with the production of about 6 Standard Operating Procedures (SOPs) in each block, a total of about 25. The quality system is based on ISO 13485: 2016 and suitable parts from ISO 14971, IEC 62366-1, IEC 62304 and IVDR 2017/746. The quality system has been built to fit in with the Microsoft Sharepoint architecture. The work has been carried out with the help of a subcontractor. QAdvis (www.qadvis.com). During the work, we have had weekly meetings with QAdvis, partly to follow the project´s development but also to ensure competence transfer.