Medical device compliance is essential to ensure that each product is safe and effective for its intended use. It encompasses various aspects, including regulatory, clinical and technical, ensuring that the device complies with current legal and normative requirements. European standards and regulations Initially, the medical device manufacturer must meet the general requirements of the European Union regulation (2017/745). There are in fact several standards that are adapted to each type of med...

At a time when the world is undergoing profound change and the quest for meaning has become essential in today’s society, thinking in terms of the long term and positive impact is a fundamental necessity for any entrepreneurial adventure. With this in mind, Procope Medicals intends to place people at the heart of its project, and by initiating this reflection with its team, the company is determined to develop a Corporate Social Responsibility approach that will evolve with time and the co...

Remote Patient Monitoring (RPM) solutions can predict, prevent and manage events through continuous remote monitoring....

The hemocompatibility (blood compatibility) of materials is a major issue in the design of medical devices, particularly artificial hearts....

Studies show that women die at a systematically higher rate than men when waiting for a donor heart....