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Recent research projects [1], [2], [3] show an increasing trend from standalone medical devices to heterogeneous networks of medical devices. This poses new challenges in the field of admission and asks for novel methods to verify the network system's correct functioning and guarantee for the patients safety. The traditional, monolithic admission approach is not feasible in this case because detailed...
Medical devices are becoming ever more complex through constant integration of new technologies. From a regulatory perspective guaranteeing safety and low risks associated with these devices is becoming increasingly challenging for device manufacturers. This work is based on a previously developed novel software tool for risk management of medical devices. The software implements relational links...
Below we present a new method to obtain quantitative measurements in medical images of a tracked video endoscope. Such quantitative measurements can be critical biomarkers during endoscopic diagnosis, e.g. for the classification of tumors and polyps. Size-based classifications are often achieved by mere visual estimation which can be imprecise and subjective. To this day established systems of quantitative...
China's medical device market is continuously growing since the last decade and increasingly attractive for foreign medical device manufacturers. However, marketing products in China as a foreign manufacturer is challenging due to the rapidly changing regulatory environment and lack of available information and documents published in English. This work addresses the recent introduction of the China...
The image to patient registration process is the longest non operative process on navigated surgery. Markerless registration using laser scan surface registration techniques comes with inaccuracies up 9mm due to user errors and to durations of up to over 15 minutes. In this study different patterns were examined in their influence of registration accuracy. On a patient's head phantom, point clouds...
Skin and bone phantoms become more and more a relevant for many applications. In this paper we present novel three dimensional, multi-layered skin and bone phantoms. The phantoms consist of four layers, representing human skin layers epidermis, dermis, subcutis/muscle and bone. Phantoms for different ethnicities and age groups as well as phantoms representing different regions of the human body have...
A vast amount of international research projects has recently been dealing with the development of an open communication standard to enhance medical device interoperability. Most approaches target a service oriented architecture based on Ethernet bus systems. Medical devices are connected to the bus and provide or consume data and applications via so-called services. For automatic discovery of device...
This work presents a novel software tool intended to support compilation of coherent technical documentation. It is based on a relational database system serving as knowledge base incorporating information from the European Medical Device Directive and harmonized standards such as ISO 14971, ISO 980 or ISO 10993-x. In order to achieve increased consistency among sections of documentation for medical...
In this paper the concept of a novel software tool for dynamic generation of technical documentation of medical devices is presented. The system is based on a relational database and increases reciprocity between sections of the technical documentation (e.g. intended purpose, classification, risk analysis, verifications and tests) through relational links. An algorithm for semi-automatic classification...
Accurate three dimensional scanning of surfaces, especially on humans, is more and more relevant. The usage of laser projection systems is widespread. However, a medical certification Class I, high accuracy, a flexible and not static handling as well as the ability to record from more than one direction has never been combined in a single device. Our project aims at the ideal setting for an easy to...
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