MP: Quality Management System to meet requirements on declaration of conformity for medical device registration in international markets

This project aims at introducing precision medicine for improvement of cardiac resynchronization therapy (CRT) for heart failure. Heart failure is the leading cause of death and morbidity in the western world. 30% of all patients with heart failure need treatment with CRT caused by conduction defects in the hearts conduction system. The conduction defect generates an ineffective pump function of the heart chambers. The conduction defect can be treated with CRT by placing pacemaker leads in the left and right heart chamber and thereby restore a synchronous and effective pump function. More than 100000 patients receive such treatment every year in the US and Europe. Despite the treatment being effective, more than 30-50% of all patients treated have no effect of the treatment but are still lifelong exposed to unwanted negative effects. The prognosis of this group of patients remains poor. We have developed methods to better target patients who will have benefits from the treatment, and to find the right way of implementing treatment. In this way we will be able to convert from a low responder rate to almost 100% responder rate, avoiding implantations in patients with no benefit. This will allow effective treatment at lower cost, providing the right treatment to the right patient at the right time! In this project, we will develop a quality management system according to the ISO-standard, in order to meet the international requirements for producing and selling a medical device (either as software or hardware). The process of implementing a QMS is critical and important for a company at an early stage in the company life-cycle, and will help us in the process of commercialization towards international markets.

eart Failure (HF) affects >38 M patients globally with an economic burden of 100billUSD per year. CRT is the of most effective and established treatment for HF. CRT consists of implantation of a resynchronization pacemaker to restore synchronous heart contractions, reducing mortality and morbidity. However, 30-50% of patients do not obtain any clinical benefit or might even get worse from the procedure. Time to onset of myocardial synergy (TD), measured with the PaCRTool-sensors, has the potential to become the new gold-standard biomarker for CRT implantation. It allows the Physician, real-time, to determine the presence of reversible dyssynchrony in the patients heart and to validate the effect of therapy (optimization). This project have enabled the implementation of a required quality management system for verification and validation of the developed medical equipment that is required for marketing of such a device.