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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...
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...
In this paper we compare and evaluate different time segments of patient handling transfer techniques at a residential nursing home for the elderly. Nursing personnel were accompanied over three weeks and transfer techniques between bed and chair were recorded with a stopwatch. The total transfer time of a patient transfer is divided into three segments: preparation, transfer and dismantling time...
This paper describes a squeegee device for a manual microassembly system. The device consists basically of a height axis, of a squeegee clamp, and of a squeegee blade. The squeegee device is connected via a supporting arm to the base frame of a microassembly system. The objective of this work is to obtain a homogenous, thin, and defined adhesive layer for piezoelectric actuators which are used in...
This paper describes the development and the application of a low-cost manual micro assembly system with an integrated heater. The presented system consists basically of a massive frame to dampen vibrations, of an observation unit, of a heating element with a 2-point temperature controller, and of an exchangeable vacuum gripper for the deposition of a work piece on a target substrate which is mounted...
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