mdcpp.com - /doc/doctemp/MDR有源产品注册模板/
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2024/4/9 11:05 32590 MY001-00 Cover page and contents.docx
2024/4/9 11:05 46652 MY001-000 前言.docx
2024/4/9 11:05 42190 MY001-01 Device description and specification.docx
2024/4/9 11:05 25735 MY001-01-1.1 List of CE marked products.docx
2024/4/9 11:05 24809 MY001-01-1.10 Certificates of analysis of suppliers.docx
2024/4/9 11:05 26441 MY001-01-1.11 Overview of generations and similar devices.docx
2024/4/9 11:05 35501 MY001-01-1.12 Market analysis.docx
2024/4/9 11:05 24609 MY001-01-1.2 EU Application Annex ABC.docx
2024/4/9 11:05 24722 MY001-01-1.3 Design Specification.docx
2024/4/9 11:05 24691 MY001-01-1.4 Risk class of the device.docx
2024/4/9 11:05 24948 MY001-01-1.5 List of available accessories, combined devices.docx
2024/4/9 11:05 25834 MY001-01-1.6 Valid certificate references for accessories, combined devices.docx
2024/4/9 11:05 24717 MY001-01-1.7 List of all configurations variants.docx
2024/4/9 11:05 24601 MY001-01-1.8 Material safety data sheets.docx
2024/4/9 11:05 24699 MY001-01-1.9 Bill of Materials.docx
2024/4/9 11:05 31570 MY001-02 Labelling of device and packaging.docx
2024/4/9 11:05 133026 MY001-02-2.1 Labels.docx
2024/4/9 11:05 31211 MY001-03 Instruction for use.docx
2024/4/9 11:05 25230 MY001-03-3.1 Instructions for use.docx
2024/4/9 11:05 39219 MY001-04 Design Information.docx
2024/4/9 11:05 24706 MY001-04-4.1 Design information.docx
2024/4/9 11:05 26861 MY001-04-4.2 Explanation of which tests are relevant to the current device.docx
2024/4/9 11:05 25667 MY001-04-4.3 History of design changes for already marketed devices.docx
2024/4/9 11:05 37110 MY001-05 Manufacturing Information.docx
2024/4/9 11:05 24578 MY001-05-5.1 Manufacturing information, manufacturing flow chart.docx
2024/4/9 11:05 24476 MY001-05-5.10 Final inspection record.docx
2024/4/9 11:05 26099 MY001-05-5.2 References to manufacturing process validations and test method validations.docx
2024/4/9 11:05 24595 MY001-05-5.3 Description of subcontracted processes.docx
2024/4/9 11:05 25647 MY001-05-5.4 Certificates of critical suppliers.docx
2024/4/9 11:05 25678 MY001-05-5.6 Information on critical suppliers and subcontractors.docx
2024/4/9 11:05 24973 MY001-05-5.7 Information on supplier control.docx
2024/4/9 11:05 25831 MY001-05-5.8 Incoming inspection records.docx
2024/4/9 11:05 25625 MY001-05-5.9 In-process inspection record.docx
2024/4/9 11:05 37382 MY001-06 Applied standards list and GSPR checklist.docx
2024/4/9 11:05 135923 MY001-06-6.1 Checklist for GSPR Compliance Analysis.docx
2024/4/9 11:05 26987 MY001-06-6.2 List of Harmonised Standards.docx
2024/4/9 11:05 24642 MY001-06-6.3 Common Specifications.docx
2024/4/9 11:05 26611 MY001-06-6.4 Other solutions.docx
2024/4/9 11:05 24716 MY001-06-6.5 Gap analysis.docx
2024/4/9 11:05 32849 MY001-07 Benefit-risk analysis and risk management.docx
2024/4/9 11:05 37372 MY001-07-7.1 Risk management procedure.docx
2024/4/9 11:05 51525 MY001-07-7.2 Risk Management Plan.docx
2024/4/9 11:05 95985 MY001-07-7.3 Risk Management Report.docx
2024/4/9 11:05 47284 MY001-08 Product Verification and validation.docx
2024/4/9 11:05 23408 MY001-08-8.1 Simulated use test.docx
2024/4/9 11:05 31161 MY001-08-8.2 Biocompatibility Evaluation Report.docx
2024/4/9 11:05 23316 MY001-08-8.2.1 Biocompatibility test protocols and reports.docx
2024/4/9 11:05 33916 MY001-08-8.2.2 Overall biological safety assessment.docx
2024/4/9 11:05 23371 MY001-08-8.2.3 Evidence of qualification of experts.docx
2024/4/9 11:05 23467 MY001-08-8.2.4 Qualification of test laboratories.docx
2024/4/9 11:05 23296 MY001-08-8.3.1 Material characterisation test protocols and reports.docx
2024/4/9 11:05 23361 MY001-08-8.3.2 Qualification of test laboratories.docx
2024/4/9 11:05 30725 MY001-08-8.4 Electrical safety test.docx
2024/4/9 11:05 30696 MY001-08-8.5 EMC test.docx
2024/4/9 11:05 30991 MY001-08-8.6 Usability engineering file.docx
2024/4/9 11:05 53369 MY001-08-8.6.1 IEC 62366-2015 Conformance Report.docx
2024/4/9 11:05 421130 MY001-08-8.6.2 Usability Engineering Process Program.docx
2024/4/9 11:05 62034 MY001-08-8.6.3 Usability Engineering Report.docx
2024/4/9 11:05 56085 MY001-08-8.6.4 User Interface Evaluation Plan.docx
2024/4/9 11:05 51996 MY001-08-8.6.5 Formative Evaluation report.docx
2024/4/9 11:05 65851 MY001-08-8.6.6 Summative Evaluation report.docx
2024/4/9 11:05 24521 MY001-08-8.6.6.1 Summative Evaluation record.docx
2024/4/9 11:05 31196 MY001-08-8.7 Software Document.docx
2024/4/9 11:05 199528 MY001-08-8.7.1 Software Description.docx
2024/4/9 11:05 29871 MY001-08-8.7.10 software Traceability Analysis.docx
2024/4/9 11:05 26573 MY001-08-8.7.11 software release.docx
2024/4/9 11:05 26617 MY001-08-8.7.12 Unresolved Anomalies.docx
2024/4/9 11:05 75608 MY001-08-8.7.13 EN62304 checklist Compliance Report.docx
2024/4/9 11:05 26126 MY001-08-8.7.2 Software development plan.docx
2024/4/9 11:05 26896 MY001-08-8.7.3 Software requirements analysis.docx
2024/4/9 11:05 27377 MY001-08-8.7.4 Software architectural design.docx
2024/4/9 11:05 25620 MY001-08-8.7.5 Software detailed design.docx
2024/4/9 11:05 32342 MY001-08-8.7.6 Software Development Environment Description.docx
2024/4/9 11:05 29485 MY001-08-8.7.7 Software unit implementation and verification.docx
2024/4/9 11:05 29569 MY001-08-8.7.8 Software integration and integration testing.docx
2024/4/9 11:05 29523 MY001-08-8.7.9 Software systems testing.docx
2024/4/9 11:05 25026 MY001-08-8.8 Cybersecurity documentation.docx
2024/4/9 11:05 32598 MY001-09 Device packaging and transportation.docx
2024/4/9 11:05 32213 MY001-09-9.1 Packaging and transportation test report.docx
2024/4/9 11:05 34458 MY001-10 Sterilization, disinfection, and reprocessing.docx
2024/4/9 11:05 120910 MY001-10-10.1 Shelf life verification protocol and report.docx
2024/4/9 11:05 24904 MY001-10-10.2 Re-processing validation protocols and report.docx
2024/4/9 11:05 24636 MY001-10-10.3 Disinfection verification protocol and report.docx
2024/4/9 11:05 34154 MY001-11 Clinical evaluation.docx
2024/4/9 11:05 28099 MY001-11-11.2.1 CV of evaluator.docx
2024/4/9 11:05 45412 MY001-11-11.2.2.1 Literature search protocol.docx
2024/4/9 11:05 534101 MY001-11-11.2.2.2 Literature search report.docx
2024/4/9 11:05 27146 MY001-11-11.2.3 CV of literature searcher.docx
2024/4/9 11:05 24609 MY001-11-11.2.4 The literatures used for analysis.docx
2024/4/9 11:05 40118 MY001-11-11.2.5 Clinical evaluation checklist.docx
2024/4/9 11:05 26289 MY001-11-11.2.6 Declaration of Interests.docx
2024/4/9 11:05 24662 MY001-11-11.2.7 IFU of Equivalent device.docx
2024/4/9 11:05 32051 MY001-11.1 Clinical Evaluation Plan.docx
2024/4/9 11:05 505246 MY001-11.2 Clinical Evaluation Report.docx
2024/4/9 11:05 33208 MY001-12 PMS plan & PSUR & PMCF.docx
2024/4/9 11:05 47122 MY001-12-12.1 Post Market Surveillance Plan.docx
2024/4/9 11:05 52701 MY001-12-12.2 Post Market Clinical Follow-up Plan.docx
2024/4/9 11:05 30729 MY001-13 Declaration of conformity.docx
2024/4/9 11:05 26321 MY001-13-13.1 Declaration of conformity.docx
2024/4/9 11:05 30989 MY001-14 Other documents.docx
2024/4/9 11:05 25746 MY001-14-14.1 European Authorized Representation Agreement.docx