Interoperability and Connectivity of Medical Devices
Medical devices are becoming hugely complex, with the complexity increasing all the time due to the fast technology progress. Most devices are now connected as a system to computer networks and databases. Interoperability (communications among devices as well as between the devices and computer systems) is increasingly important. Modern miniaturized devices are often attached to human body or are implanted in the body. Point-of-care devices are used in remote locations for testing patients yet they must be connected to a common enterprise informatics system. Increasingly surgical operations are performed using laparoscopy and robotics to reduce the invasive and risky procedures. All medical devices are subject to strict safety and legal regulations.
The LMU course on systems engineering in medical devices will provide the student an understanding of the regulated medical device development process, and how systems engineering is applied in this domain. Topics include design and development planning, design inputs, design outputs, design reviews, verification, validation, design transfer, design change control, design history files, human factors, and risk management. Each of these is covered in detail to provide and understanding of systems engineering in the medical device domain. General principles for applying systems engineering in commercial development applications will be covered and contrasted with the more traditional approaches.