MDR-adjustment of system for digital arrhythmia diagnostics

Purpose and goal:

In this project, Zenicor, in collaboration with external MDR-expertise, has succeeded in preparing the organization, the quality system and its products in order to be able to initiate the MDR certification process at its Notified body. This is to be able to transition from MDD to MDR. A transition to MDR is a prerequisite for Zenicor to successfully open up for the continued commercialization and utilization of intermittent ECGs in existing and emerging markets in Europe.

Expected results and effects:

During the project, Zenicor´s staff has deepened their knowledge of MDR. The quality system has been updated to meet the MDR requirements required May 26, 2021. A Clinical Evaluation Plan according to the MDR has been developed and product updates regarding the UDI and registration in Eudamed have been completed.

Clinical evaluation and cyber security have also been handled within the project. The content of the documentation for a "TD review" according to MDR at the Notified Body is established. Further adjustments to the quality system to meet all MDR requirements established. Approach and implementation:

The project was carried out in collaboration with MDR expertise. After analysis of the MDR requirements, a number of areas were identified such as QMS, clinical evaluation, UDI, Eudamed, cyber security that are significantly affected by MDR. In consultation with the MDR experts, the necessary documentation has been prepared in order to be able to carry out a "Technical Documentation review" according to MDR by the Notified Body.

Furthermore, adjustments to the QMS to meet all MDR requirements is established to enable an "MDR audit" by the Notified Body.