Danger to public health: medical devices, toxicity, virus and fraud
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Danger to public health : medical devices, toxicity, virus and fraud. / Kierkegaard, Sylvia; Kierkegaard, Patrick.
In: Computer Law & Security Review, Vol. 29, No. 1, 2013, p. 13-27.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Danger to public health
T2 - medical devices, toxicity, virus and fraud
AU - Kierkegaard, Sylvia
AU - Kierkegaard, Patrick
PY - 2013
Y1 - 2013
N2 - The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient’s safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.
AB - The recent scandals involving the sale and manufacture of defective medical devices such as the PIP breast implants and the De Puy Implants have resulted in the long-awaited modernisation of the Medical Device Directive. Taking cognizance of the increasing integration of medical devices and technology, as well as the importance of electronic information, the proposed EU Regulation on Medical Devices promises greater European control on Notifying Bodies and more transparency to ensure patient’s safety. This paper discusses the current directives and proposed legislation as well as the liabilities of manufacturers and software vendors for product failure.
U2 - 10.1016/j.clsr.2012.11.006
DO - 10.1016/j.clsr.2012.11.006
M3 - Journal article
VL - 29
SP - 13
EP - 27
JO - Computer Law and Security Review
JF - Computer Law and Security Review
SN - 0267-3649
IS - 1
ER -
ID: 43223457