CE临床评估要求和搜索网站

临床评估要求和搜索网站讲师介绍•欧盟公告机构Notified Body 0120之EN ISO 9001, EN 医疗器械专家ISO 13485及MDD 主任审核员, 医疗器械专家。•CB证书签证官•产品安全测试及认证资深工程师、技术审核员国际审核员注册协会注册主任审核员•加拿大卫生局CMDCAS主任审核员•全国消毒技术与设备标准化技术委员会委员•全国齿科设备与器械分技术委员会委员•广东省医疗器械设备计器械标准化技术委员会委员•拥有12年国际测试、认证发证经验及丰富的审核和讲课经验1Clinical Evaluation 临床评估References for Clinical Evaluation 1) Directive 93/42/EEC: Article 1/2k; Annex X 2) MEDDEV 2 7 1 Rev 3ISO 134852) MEDDEV 2.7.1 Rev 3 3) MHRA note on Equivalency 4) MEDDEV 2.12/2 rev 2 PMCF 5) EN ISO 14155:2011 6) FDA Guidance on Benefit-Risk Determination draft 7) GHTF Guidances Clause 7.3.6 Clause 7.1 1) ~4) 是强制的 The first 4 are mandatory guidance 在技术文档评审和现场QMS审核时需要包含临床评估Needed for reviewing technical files and auditing the QMS 2References for Clinical Evaluation 1) Directive 93/42/EEC: Article 1/2k; Annex X 2) MEDDEV 2 7 1 Rev 3ISO 134852) MEDDEV 2.7.1 Rev 3 3) MHRA note on Equivalency 4) MEDDEV 2.12/2 rev 2 PMCFU 5) EN ISO 14155: 2011 6) FDA Guidance on Benefit-Risk Determination draft 7) GHTF Guidances Clause 7.3.6 Clause 7.1 1) ~4) 是强制的The first 4 are mandatory guidance 在技术文档评审和现场QMS审核时需要包含临床评估Needed for reviewing technical files and auditing the QMS Directiv e 93/42/EEC Annex X 1.1a In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data. 3Clinical Data 临床数据Definition Safety and/or performance information that are generated from the use of a medical devices通过对医疗器械的使用而得定义generated from the use of a medical devices 到的与器械的安全和/...