Commercialisation and quality requirements of biomedical wearable and implantable devices
Galeti, Ekram (2013)
2013
Master's Degree Programme in Biomedical Engineering
Tieto- ja sähkötekniikan tiedekunta - Faculty of Computing and Electrical Engineering
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Hyväksymispäivämäärä
2013-08-14
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:tty-201308191282
https://urn.fi/URN:NBN:fi:tty-201308191282
Tiivistelmä
Due to growing old age population and increase in chronic diseases at all the ages across the world, there is an opportunity for Biomedical device companies for a vital investment and address the problems by introducing risk free, effective, and safe devices into the market. Presently, the market for Biomedical Wearable and Implantable devices is in high demand due to wider applications and advance in computing algorithms in Medical industry.
The current thesis has been focused on commercialising and quality requirements of Biomedical Wearable and Implantable devices by understanding the market requirements and increase in global demand for quality devices. In order to manufacture an effective Biomedical device, manufactures have to establish quality management systems in every phase of product development phase to produce safe and effective devices, and meet the requirements of regulatory authorities who in turn are answerable to the public. These Biomedical devices can extend and give quality life to the patient sufferings.
Though companies see a profitable business for these innovative Biomedical devices, stringent requirements and longer approval time process from regulatory authorities are making the Biomedical device companies to rethink to enter the market in these Biomedical devices. Moreover, regulatory authorities should consider adopting the global nomenclature and standards due to increasing global demand supply chain management for these devices.
The current thesis has been focused on commercialising and quality requirements of Biomedical Wearable and Implantable devices by understanding the market requirements and increase in global demand for quality devices. In order to manufacture an effective Biomedical device, manufactures have to establish quality management systems in every phase of product development phase to produce safe and effective devices, and meet the requirements of regulatory authorities who in turn are answerable to the public. These Biomedical devices can extend and give quality life to the patient sufferings.
Though companies see a profitable business for these innovative Biomedical devices, stringent requirements and longer approval time process from regulatory authorities are making the Biomedical device companies to rethink to enter the market in these Biomedical devices. Moreover, regulatory authorities should consider adopting the global nomenclature and standards due to increasing global demand supply chain management for these devices.