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Medical device design process

2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2009
The current design process is a combination of methods from engineering disciplines, government regulatory agencies (domestic and international) and independent certification and compliance companies. The goal of the processes that have been developed is to be certain that a new product meets the users expectations, is safe and effective in providing ...
Byron L, Gilman   +2 more
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Designing Eco-Friendly Medical Devices

IEEE Pulse, 2022
For most of the 20 years that Carol Stillman has helped companies design medical devices, sustainability has always come second to other concerns. "There was a perception that it just wasn't something that made sense for medical device companies to do, because the safety and efficacy was so important," says Stillman, a project and program manager at ...
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Teaching medical device design using design control

Expert Review of Medical Devices, 2012
The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific ...
Karen, May-Newman, G Bryan, Cornwall
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Design Considerations For Medical Device Manufacturers

Biomedical Instrumentation & Technology, 2012
As technology advances, so does the complexity of reusable medical devices. This creates greater challenges for cleaning, disinfecting, and sterilizing devices between patient uses. There is increasing concern from the U.S. Food and Drug Administration (FDA) and the reusable device industry that inadequately reprocessed devices are contributing to ...
Alpa, Patel   +2 more
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Revolutionizing medical device design

2013 IEEE International Conference of Electron Devices and Solid-state Circuits, 2013
Summary form only given. The vision of the Medical Electronic Device Realization Center (MEDRC) is to facilitate the microelectronics and medical device industry in the transformation of medical electronic devices as it has successfully demonstrated in computation, communication and consumer electronics. The successful realization of such a vision also
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Design Protection for Medical Devices

2019
Design patent protection maybe granted for the ornamental design of a functional item, such as a medical device, so long as the design is novel and non-obvious. Not only can design patent protection be sought for the overall appearance of a medical device, but protection can also be sought for individual components of a medical device, including ...
Gerald B. Halt   +5 more
openaire   +1 more source

Reliable Design of Medical Devices

Physiological Measurement, 1998
The development of a medical device is a complex process. It requires the integration of a range of diverse disciplines, activities, and regulatory requirements, all of which must be achieved to ensure that the final result is a safe, effective and competitive product.
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Exploring Medical Device Interface Design

Proceedings of the Human Factors and Ergonomics Society Annual Meeting, 2015
An effective user interface has become a key success factor in the use of self-managed medical devices such as glucose monitoring for diabetic patients. As the quantified-self movement expands, more users are adopting this category of device. Adoption depends on technology acceptance by an aging population with limited expertise but extensive ...
Marc L. Resnick, Rui Wang
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Low Cost Hand-Tracking Devices to Design Customized Medical Devices

2015
This paper concerns the development of a Natural User Interface (NUI) for lower limb prosthesis design. The proposed solution exploits the Leap Motion device to emulate traditional design tasks manually performed by the prosthetist. We first illustrate why hand-tracking devices can be adopted to design socket of lower limb prosthesis using virtual ...
COLOMBO, Giorgio   +3 more
openaire   +3 more sources

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