mdcpp.com - /doc/doctemp/I 类医疗器械TCF技术文档模板/

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  2024/4/9    11:04        32972 MT001-0.0 content.docx
  2024/4/9    11:04        28204 MT001-1.0 Rationale for the qualification.docx
  2024/4/9    11:04        28973 MT001-10.0 Pre-clinical and Clinical evaluation data.docx
  2024/4/9    11:04        28372 MT001-10.1 Pre-clinical study.docx
  2024/4/9    11:04        22089 MT001-10.1-1 Product stability (real time) test report.docx
  2024/4/9    11:04        35610 MT001-10.2-1 Clinical Evaluation Plan.docx
  2024/4/9    11:04        68865 MT001-10.2-2 Clinical evaluation report.docx
  2024/4/9    11:04        19938 MT001-10.2-3 Literature.docx
  2024/4/9    11:04        32567 MT001-10.3-1 POST-MARKET CLINICAL FOLLOW-UP control Procedure.docx
  2024/4/9    11:04        48352 MT001-10.3-2 Post-market clinical follow-up plan.docx
  2024/4/9    11:04        27191 MT001-11.0 Records-DOC and certificates.docx
  2024/4/9    11:04        27552 MT001-11.1  EU declaration of conformity.docx
  2024/4/9    11:04        19883 MT001-11.2 EN ISO 13485 certificate.docx
  2024/4/9    11:04        27229 MT001-12.0 Others.docx
  2024/4/9    11:04        28990 MT001-12.1 Product List.docx
  2024/4/9    11:05        23275 MT001-12.2 Resume of regulatory compliance personnel.docx
  2024/4/9    11:05        27130 MT001-13.0 EC Authorized Representation Agreement.docx
  2024/4/9    11:05        19984 MT001-13.1 EC Authorized Representation Agreement.docx
  2024/4/9    11:05        28467 MT001-14.0 The post-market surveillance system.docx
  2024/4/9    11:05        41489 MT001-14.1 PMS Plan.docx
  2024/4/9    11:05        41867 MT001-14.2 PMS Report.docx
  2024/4/9    11:05        35715 MT001-2.0 Description and specification.docx
  2024/4/9    11:05        28129 MT001-3.0 Technical Specifications of the device.docx
  2024/4/9    11:05        28395 MT001-4.0 Information to be supplied by the manufacturer.docx
  2024/4/9    11:05        19987 MT001-4.1 User Mannual.docx
  2024/4/9    11:05        19977 MT001-4.2 Label.docx
  2024/4/9    11:05        26967 MT001-5.0 Reference to previous generations and to similar devices.docx
  2024/4/9    11:05        33290 MT001-6.0 Design and manufacturing information.docx
  2024/4/9    11:05        24163 MT001-7.0 General safety and performance requirements.docx
  2024/4/9    11:05       144778 MT001-7.1 Checklist for General safety and performance requirements Compliance analysis.docx
  2024/4/9    11:05        29373 MT001-8.0 Demonstration of conformity.docx
  2024/4/9    11:05        26434 MT001-9.0 Benefit-risk analysis and Risk management.docx