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Global Regulatory Requirements for Medical Devices
Mälardalens högskola, Akademin för hållbar samhälls- och teknikutveckling.
2008 (engelsk)Independent thesis Basic level (professional degree), 20 poäng / 30 hpOppgave
Abstract [en]

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.

The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

sted, utgiver, år, opplag, sider
Akademin för hållbar samhälls- och teknikutveckling , 2008. , s. 51
Emneord [en]
medical devices, quality, regulations, classification, risk management
Emneord [sv]
medicinsk teknik, kvalitet, regelverk, klassificering, riskhantering
HSV kategori
Identifikatorer
URN: urn:nbn:se:mdh:diva-700OAI: oai:DiVA.org:mdh-700DiVA, id: diva2:121327
Presentation
2008-05-14, K338, Verktyget, Smedjegatan 37, Eskilstuna, 09:00
Uppsök
teknik
Veileder
Examiner
Tilgjengelig fra: 2008-06-05 Laget: 2008-06-05

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