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2024/4/9 11:10 189952 MT002-000-00-Table of content for MDR Technical Document.doc
2024/4/9 11:10 113381 MT002-001-Part A-Device Description and Specifications including Variants and Accessories.doc
2024/4/9 11:10 45568 MT002-002-Annex A.1 BOM.doc
2024/4/9 11:10 69120 MT002-003-Part B-Information to be supplied by the Manufacturer.doc
2024/4/9 11:10 112519 MT002-004-Annex B.1 Device labelling.doc
2024/4/9 11:10 61383 MT002-005-Annex B.2 Sterile packaging labelling.doc
2024/4/9 11:10 38848 MT002-006-Annex B.3 Single unit packaging labelling.doc
2024/4/9 11:10 38852 MT002-007-Annex B.4 Sales packaging labelling.doc
2024/4/9 11:10 186943 MT002-008-Annex B.5 Transport packaging labelling.doc
2024/4/9 11:10 18432 MT002-009-Annex B.6 Instructions for use.doc
2024/4/9 11:10 18432 MT002-010-Annex B.7 Patient handbook.doc
2024/4/9 11:10 18432 MT002-011-Annex B.8 Physicians handbook.doc
2024/4/9 11:10 18432 MT002-012-Annex B.9 Implant card information.doc
2024/4/9 11:10 18432 MT002-013-Annex B.10 Electronic IFU (e-IFU) information.doc
2024/4/9 11:10 18432 MT002-014-Annex B.11 Copies of promotional materials.doc
2024/4/9 11:10 107445 MT002-015-Part C-Design and Manufacturing Information.doc
2024/4/9 11:10 531729 MT002-016-Part D-General Safety and Performance Requirements.doc
2024/4/9 11:10 66048 MT002-017-Part E-Benefit-Risk Analysis and Risk Management.doc
2024/4/9 11:10 86016 MT002-018-Annex E.1 Risk management control procedures.doc
2024/4/9 11:10 134582 MT002-019-Annex E.2 Risk Management Plan.doc
2024/4/9 11:10 311303 MT002-020-Annex E.3 Risk Management Report.doc
2024/4/9 11:10 114766 MT002-021-Part F-Pre-clinical Information.doc
2024/4/9 11:10 433335 MT002-022-Annex F.1 EN62304 checklist Compliance Report.doc
2024/4/9 11:10 204288 MT002-023-Annex F.1-1 Software Description.doc
2024/4/9 11:10 26624 MT002-024-Annex F.1-2 Software development plan.doc
2024/4/9 11:10 32254 MT002-025-Annex F.1-3 Software requirements analysis.doc
2024/4/9 11:10 32517 MT002-026-Annex F.1-4 Software architectural design.doc
2024/4/9 11:10 26622 MT002-027-Annex F.1-5 Software detailed design.doc
2024/4/9 11:10 64454 MT002-028-Annex F.1-6 Software Development Environment Description.doc
2024/4/9 11:10 45568 MT002-029-Annex F.1-7 Software unit implementation and verification.doc
2024/4/9 11:10 45568 MT002-030-Annex F.1-8 Software integration and integration testing.doc
2024/4/9 11:10 45568 MT002-031-Annex F.1-9 Software systems testing.doc
2024/4/9 11:10 52466 MT002-032-Annex F.1-10 software Traceability Analysis.doc
2024/4/9 11:10 33878 MT002-033-Annex F.1-11 software release.doc
2024/4/9 11:10 31232 MT002-034-Annex F.1-12 Unresolved Anomalies.doc
2024/4/9 11:10 18944 MT002-035-Annex F.2 Cybersecurity documentation.doc
2024/4/9 11:10 23552 MT002-036-Annex F.3 Stability(shelf-life) validation protocols and report.doc
2024/4/9 11:10 591621 MT002-037-Annex F.4-1 IEC 62366-2015 Conformance Report.doc
2024/4/9 11:10 357237 MT002-038-Annex F.4-2 Usability Engineering Process Program.doc
2024/4/9 11:10 84463 MT002-039-Annex F.4-3 The team group of USABILITY ENGINEERING.doc
2024/4/9 11:10 79360 MT002-040-Annex F.4-4 Use specification.doc
2024/4/9 11:10 114250 MT002-041-Annex F.4-5 Identify User Interface characteristics.doc
2024/4/9 11:10 131402 MT002-042-Annex F.4-6 Identify known or foreseeable Hazard and Hazardous Situations.doc
2024/4/9 11:10 235386 MT002-043-Annex F.4-7 Identify and select Hazard-related use scenarios.doc
2024/4/9 11:10 74240 MT002-044-Annex F.4-8 User Interface Specification.doc
2024/4/9 11:10 128660 MT002-045-Annex F.4-9 User Interface evaluation plan.doc
2024/4/9 11:10 21098 MT002-046-Annex F.4-10 Formative Evaluation report.doc
2024/4/9 11:10 21150 MT002-047-Annex F.4-11 Summative Evaluation report.doc
2024/4/9 11:10 21496 MT002-048-Annex F.4-12 User Interface of Unknown Provenance.doc
2024/4/9 11:10 19456 MT002-049-Annex F.5 Packaging validation protocol and report.doc
2024/4/9 11:10 18432 MT002-050-Annex F.6 transport testing protocols and report.doc
2024/4/9 11:10 68671 MT002-051-Part G-Clinical Evaluation, PMS and PMCF.doc
2024/4/9 11:10 64106 MT002-052-Annex G.1-1 Clinical Evaluation Plan.doc
2024/4/9 11:10 794341 MT002-053-Annex G.1-2 Clinical evaluation report.doc
2024/4/9 11:10 33280 MT002-054-Annex G.1-3 CV of evaluators.doc
2024/4/9 11:10 30586 MT002-055-Annex G.1-4 CV of searcher.doc
2024/4/9 11:10 25600 MT002-056-Annex G.1-5 Declaration of Interests.doc
2024/4/9 11:10 18432 MT002-057-Annex G.1-6 Copies of literature articles.doc
2024/4/9 11:10 17920 MT002-058-Annex G.1-7 CE Certificate of Equivalent devices.doc
2024/4/9 11:10 132642 MT002-059-Annex G.1-8 Literature search protocol.doc
2024/4/9 11:10 676072 MT002-060-Annex G.1-9 Literature search report.doc
2024/4/9 11:10 17920 MT002-061-Annex G.1-10 Clinical investigation.doc
2024/4/9 11:10 19456 MT002-062-Annex G.2 Summary of Safety and Clinical Performance.doc
2024/4/9 11:10 91180 MT002-063-Annex G.3-1 Post-market surveillance control Procedure.doc
2024/4/9 11:10 138489 MT002-064-Annex G.3-2 Post-market surveillance Plan.doc
2024/4/9 11:10 18944 MT002-065-Annex G.3-3 Periodic Safety Update Report.doc
2024/4/9 11:10 75278 MT002-066-Annex G.4-1 Post-market surveillance control Procedure.doc
2024/4/9 11:10 204103 MT002-067-Annex G.4-2 Post-market clinical follow-up plan.doc
2024/4/9 11:10 18944 MT002-068-Annex G.4-3 Post market clinical follow-up report.doc
2024/4/9 11:11 104448 MT002-069-Annex G.5-1 Vigilance system control procedures.doc
2025/2/12 9:24 833052 MT002-070-Annex G.5-1-Form 1-Manufacturer Incident report.pdf
2024/4/9 11:11 186123 MT002-071-Annex G.5-1-Form 2-Field Safety Corrective Action（FSCA）.pdf
2024/4/9 11:11 357639 MT002-072-Annex G.5-1-Form 3-Field Safety Notice(FSN).pdf
2024/4/9 11:11 84286 MT002-073-Annex G.5-1-Form 4-Periodic Summary Report.pdf
2024/4/9 11:11 82660 MT002-074-Annex G.5-1-Form 5-Trend Report.pdf
2024/4/9 11:11 61229 MT002-075-Part H- Information related to Special Substances.doc
2024/4/9 11:11 61952 MT002-076-Part I - Sterilisation and Information related to re-usable surgical instruments.doc
2024/4/9 11:11 39459 MT002-077-Part J-Declaration of Conformity.doc
2024/4/9 11:11 17920 MT002-078-Annex J-1 EC Authorized Representation Agreement.doc
2024/4/9 11:11 24131 MT002-079-Annex J-2 Resume of regulatory compliance personnel.doc
2024/4/9 11:11 58049 MT002-080-Part K-Specific information for Class III Class IIb per Rule 12.doc