Medical technology whitebook

The complexity of medical devices has hugely increased over recent years. Whereas devices used to be mechanically streamlined with a stand-alone design, today’s devices are increasingly operated electronically and using software. Ultrasound devices, infusion pumps, ventilators, diagnostic workstations, robot-controlled process and telemedicine are just a few examples of these types of modern devices.

The more complex the products, the more likely there are to be specific risks associated with their use. Users and operating companies both play a role in reducing the risks associated with medical devices and in increasing patient and user safety by complying with obligations relating to briefings and reporting. In accordance with the German Medical Devices Act (MPG) and the German Medical Devices Operator Ordinance (MPBetreibV), all medical devices in medical institutions must be tested at a testing interval defined by the manufacturer in accordance with DIN VDE 0751-1 / DIN IEC 62353 / DIN IEC 60601. These testing intervals are between six and 36 months.