Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 6 of 6 for “"Medical device regulation"”.
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Medical Device Regulation 2017/745: Impact, evaluation and practices for change execution
Medical Device Regulation 2017/745 (MDR) is a significant change in the regulatory framework for medical devices marketed in the European Union (EU), and globally standardised medical devices intended for international markets. This thesis examines the impact of this regulation and provides an …
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Modeling regulatory impacts on medical device supply chains
… to be an increasingly complex issue in the medical device industry. Regulations place stress on regional supply chains across the world. Most recently, the European Parliament issued the Medical Device Regulation (EU) 2017/745 instituting new compliance framework for all devices …
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Stakeholder Landscape and Regulatory Implementation of Annex XVI Products in Finland: Oversight of Medical Devices Without an Intended Medical Purpose with Reference to the European Context
… examines the implementation of Annex XVI of the Medical device regulation (EU) 2017/745 (MDR) in Finland. Annex XVI extends the MDR’s scope to include products without an intended medical purpose, such as dermal filler and intense pulsed light (IPL) devices, which have similar risk profiles and …
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Methodological challenges in the evidence synthesis of health outcomes of digital health technologies
Medical devices and pharmaceuticals are worlds apart, but healthcare would be impossible without them. Digital biomarkers are the subject of this thesis defined as objective, measurable, physiological, and behavioural parameters collected using wearable, portable, implantable, or digestible digital …
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Controllable magnetic systems for minimally invasive surgery
… of a controllable electromagnetic compression medical device that addresses the need for control of magnetic attraction in the clinical setting. This work outlines the design of a magnetic medical device to be used for anchoring or compression, namely by shaping the attraction profile between …
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Experimental and regulatory approaches for the standardisation of surgical meshes
L'abstract è presente nell'allegato / the abstract is in the attachment