Medical device manufacturers are increasingly applying artificial intelligence (AI) to innovate their products and improve patient outcomes. Health institutions also developing own algorithms, address specific needs for which no commercial product exists.Although AI-based algorithms offer good prospects improving outcomes, wide adoption in clinical practice is still limited. The most significan...

PVSio-web is a graphical environment for facilitating the design and evaluation of interactive (human-computer) systems. Using PVSio-web, one can generate and evaluate realistic interactive prototypes from formal models. PVSio-web has been successfully used over the last two years for analyzing commercial, safety-critical medical devices. It has been used to create training material for device ...

When biomedical engineers begin to conceptualize a new medical device, verification and validation (V&V) is usually at the forefront of their thoughts. They want to start the effort well by making sure that they have the right tools and processes in place for “building the product right,” and they want to be able to conclude their efforts by demonstrating that they’ve “built the right product” ...

Medical devices encompass nearly every medical product that does not achieve its intended purpose through chemical action, from the simple (tongue blades) to the complex (MRI machines), and from the safe (stethoscopes) to the risky (artificial hearts) [1,2]. Certain drug–device combinations, such as drug-eluting coronary stents, are also regulated as devices. The number and complexity of medica...

Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.

The correct processing of medical devices serves the prevention of infection and, within themulti-barrier system of hygiene measures, is indispensable in the prevention of infection in the interests of patient protection. In order to achieve the ends of preventative health protection, the hygiene, safety-technology and legal conditions must be clearly defined, and the user must be made familiar...

This paper discusses the testing of a safety-critical medical device in an industrial environment. The authors have worked on the development and testing of a cardiac rhythm management system at Guidant Corporation, which is involved in the development of a family of related medical devices. The testing process of these systems is expensive because of the stringent safety and reliability requir...

The review describes the main points of life cycle a medical device, considers three stages regulation devices: pre-market, market and post-sale. attention is paid to post-sale supervision, as an activity for monitoring used devices, collecting information about quality, safety effectiveness devices.