Medical device design within the ISO 13485 framework

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dc.contributor.advisor Cantillon-Murphy, Padraig en
dc.contributor.author O'Shea, Conor
dc.date.accessioned 2017-02-14T13:30:31Z
dc.date.issued 2017
dc.date.submitted 2017
dc.identifier.citation O'Shea, C. 2017. Medical device design within the ISO 13485 framework. PhD Thesis, University College Cork. en
dc.identifier.endpage 227 en
dc.identifier.uri http://hdl.handle.net/10468/3630
dc.description.abstract The design and development of medical devices has become an increasing complex and regulated process. Little if any consideration is given to the regulatory requirements when developing medical devices in universities. This has resulted in an imposing barrier preventing academic innovation reaching clinical adoption. The scope of universities is not to become the legal manufacturer of medical devices. However, should the development of novel devices ever aim to benefit patient care and reach a clinical setting, design controls must be implemented throughout the project life cycle to demonstrate feasibility and safety. The aim of this thesis is to develop user-centred technologies which comply with industrial design control practices whilst helping to bolster and promote innovation within academia. Four projects relating to medical devices have been designed in response to well-defined and end-user-originated clinical needs. These devices can serve as the exemplar for the framework developed in this work with each reaching staggered phases of development within a controlled design process. Although unique, the devices have significant overlapping characteristics that lend the devices to parallel development, leveraging in-house know-how and ‘lessons learned’ into the process of innovation. This thesis focuses on the novelty and design of the aforementioned projects in a discrete structured approach and reflects on the development of each project within the context of a design control process which was developed as part of this work. It is the ultimate goal of this work to develop a flexible structured system compliant with the international requirements for product design and development which may be exported internationally. However, the full execution of this ambition was limited due physical, and financial limitations. This manuscript will describe the technical and commercial opportunity of devices and reflects on the success of developing same within a design control process developed as part of this work. en
dc.description.sponsorship Irish Research Council for Science, Engineering and Technology (Grant GOIPG/2013/137) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher University College Cork en
dc.rights © 2017, Conor O'Shea. en
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/3.0/ en
dc.subject Medical devices en
dc.subject Medical device design en
dc.subject ISO 13485 framework en
dc.title Medical device design within the ISO 13485 framework en
dc.type Doctoral thesis en
dc.type.qualificationlevel Doctoral Degree (Structured) en
dc.type.qualificationname PHD (Engineering) en
dc.internal.availability Full text available en
dc.description.version Accepted Version
dc.contributor.funder Irish Research Council for Science, Engineering and Technology en
dc.description.status Not peer reviewed en
dc.internal.school Electrical and Electronic Engineering en
dc.check.reason Releasing this thesis would cause substantial prejudice to the commercial interests of University College Cork en
dc.check.opt-out Yes en
dc.thesis.opt-out true
dc.check.entireThesis Entire Thesis Restricted
dc.internal.conferring Spring 2017 en


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© 2017, Conor O'Shea. Except where otherwise noted, this item's license is described as © 2017, Conor O'Shea.
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