Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enf...

Quality Assurance and Good Manufacturing Practice in Respect of Plasma Fractionation

quality assurance and good manufacturing practice in respect of plasma fractionation

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development and implementation of an optimized control strategy for induction machine in an electric vehicle

in the area of automotive engineering there is a tendency to more electrification of power train. in this work control of an induction machine for the application of electric vehicle is investigated. through the changing operating point of the machine, adapting the rotor magnetization current seems to be useful to increase the machines efficiency. in the literature there are many approaches wh...

Quality assurance of medical software.

Quality assurance is a topical issue within the software industry, and various methodological solutions aimed at improving software quality have been proposed. Medical software is generally deemed safety-critical and, as such, should be subject to control procedures exceeding those applicable to general-purpose software. The user/purchaser of medical equipment has an important part to play in t...