New regulations for medical devices:Rationale,advances and impact on research and patient care

来源 :世界骨科杂志 | 被引量 : 0次 | 上传用户：walker250

【摘要】

：

A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators.

【作者】

：

Gerold Labek Harald Schoffl Ch

【机构】

：

DepartmentofOrthopaedicSurgery,DepartmentforTraumaSurgery,ClinicaFiosordeFoc

【出处】

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世界骨科杂志

【发表日期】

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2016年3期

【关键词】

：

ARTHROPLASTY OUTCOME RESEARCH Medical device Regulation

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A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators.Apart from clinical studies,register and routine data will play an essential role in this conte

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New regulations for medical devices:Rationale,advances and impact on research and patient care

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