Medical devices such as bandages, oxygen masks, and tongue depressors are the lowest.
Medical devices such as syringes and catheters pose intermediate levels of risk and are subject to additional regulatory controls, such as special labeling. Some Class II devices require premarket notification and pre- and post-market surveillance.
Medical devices such as heart implants, robotic surgical systems and insulin pumps pose the highest degree of patient risk, and are subject to the highest level of controls. In addition to all of the controls of Class 1 and 2 devices, Class III devices are subject to an intensive pre-market approval process (PMA) and must demonstrate rigorous quality processes, as well as ongoing post-market surveillance.
Examples of embedded systems in medical devices include defibrillators, blood pressure monitoring devices, digital flow pumps, heart monitoring machines, insulin and glucose monitors and pumps, surgical robots, pacemakers, CT and PET scanners, MRIs, mammography equipment, surgical navigation systems, and much more.
Unlike other types of software development, medical devices systems typically:
Medical devices are highly regulated in order to ensure their safety, performance, and reliability. Regulatory standards and guidelines govern not only the device quality, but also the rigor of processes used to develop and monitor them. The regulatory landscape for medical device manufacturers covers every aspect of product development, from pre-market surveillance and pre-market approval to ongoing post-market surveillance. By selecting an ALM platform with built-in support for medical device standards, organizations can streamline compliance and focus on innovation.