医疗器械质量体系QR-QP-23-02 Clinic Evaluation Report

1、Clinic Evaluation Report Page PAGE 8 of 15CONFIDENTIALDocument No.: Version:Development DocumentQR-QP-23-02RevA0Total Pages:15Project name:XXXX SUBJECT * MERGEFORMAT Document name:Clinic Evaluation ReportWritten: Auditor: Approved: DateDate:Date:Revision RecordVer.Revision descriptionRevisorDateTabl

2、e of Contents TOC o 1-3 h z HYPERLINK l _Toc327863495 Table of Contents PAGEREF _Toc327863495 h 2 HYPERLINK l _Toc327863496 Chapter1 Product information PAGEREF _Toc327863496 h 3 HYPERLINK l _Toc327863497 Chapter2 Description of the device PAGEREF _Toc327863497 h 4 HYPERLINK l _Toc327863498 2.1Princ

3、iple PAGEREF _Toc327863498 h 4 HYPERLINK l _Toc327863499 2.2structure PAGEREF _Toc327863499 h 4 HYPERLINK l _Toc327863500 2.3material PAGEREF _Toc327863500 h 6 HYPERLINK l _Toc327863501 2.4Intended Use PAGEREF _Toc327863501 h 7 HYPERLINK l _Toc327863502 2.5Technical data PAGEREF _Toc327863502 h 8 HY

4、PERLINK l _Toc327863503 2.6Warning: PAGEREF _Toc327863503 h 8 HYPERLINK l _Toc327863504 Chapter3 Choice of clinical data types PAGEREF _Toc327863504 h 9 HYPERLINK l _Toc327863505 3.1Clinical route selection PAGEREF _Toc327863505 h 9 HYPERLINK l _Toc327863506 3.1.1Data generated through literature se

5、arch PAGEREF _Toc327863506 h 9 HYPERLINK l _Toc327863507 3.1.2Data generated through clinical experience PAGEREF _Toc327863507 h 9 HYPERLINK l _Toc327863508 3.2Comparative points of the literature PAGEREF _Toc327863508 h 9 HYPERLINK l _Toc327863509 Chapter4 Summary of the clinical data &appraisal PA

6、GEREF _Toc327863509 h 11 HYPERLINK l _Toc327863510 4.1the comparison of Unimed sensor with the similar product PAGEREF _Toc327863510 h 11 HYPERLINK l _Toc327863511 4.2Clinical risk analysis and control measure PAGEREF _Toc327863511 h 12 HYPERLINK l _Toc327863512 4.3The clinical trial data of Unimed

7、Spo2 sensor PAGEREF _Toc327863512 h 12 HYPERLINK l _Toc327863513 Chapter5 Conclusion PAGEREF _Toc327863513 h 15Product informationEC Certificate Registration No.Legal ManufacturerProduct groupUMDNS NumberProduct Name(s)& modelClassification RuleClassProcedure for CertificationNotified Body Descripti

8、on of the device Principlestructurethe sensor structure chartModelDrawingmaterialTable Description of Biocompatibility about material contact with skinModelStructureMaterialTesting report numberRemarkIntended UseTechnical data1).Performance/Reliability2).Safety:3) Compatibility:4) Storage/PackagingW

9、arning:Choice of clinical data typesClinical route selection Data generated through literature search According to the “GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIEDBODIES”, Unimed sensor it can come to the clinical evaluation through by literature search.

10、We search the literature about the clinical relative of the Unimed sensor and the similar product through the literature search. Compare the Unimed sensor with the similar product of other companies in the principle, structure, performance, and clinical application. And then prove the Unimed sensor

11、is substantive equivalent with the similar product of other companies.The content of the related clinical literatures are selected for Unimed sensor clinical evaluation should meet one of the following points:Have same or similar principles and structural featuresHave same or similar performance.Hav

12、e same or similar intended use and intended purpose.Used for the same or similar clinical condition or purpose, used at the same site in the body, used in similar population.Data generated through clinical experienceComparative points of the literatureNumberName of literatureSourceCommentSummary of

13、the clinical data &appraisalthe comparison ofXXXX with the similar product The following is the comparison table of the XXXXwith the similar product of other companies which have registered in the principle, structure, performance, application. Table 1：Comparison table of the XXXX with the similar p

14、roduct which have obtained CEmarkItemXXXX XXXXComparison ManufacturerCEMark. classificationprincipleApplication scope structureMeasurement Part PerformanceStandard metIntended useApplication conclusionThrough the comparison table, we believe that our Unimed sensor is substantive equivalent with the

15、similar product of other companies which are registered in principle, structure, performance, application and so on.Clinical risk analysis and control measureThe possible potential hazards in the process of the clinical application are: Control measures: prepare a detailed directions for Use enable

16、the user to understand the device and the use methods sufficiently, as much as possible to minimize the probability of the use error. Through by taking measures to control the risks, we can think that the device in relative benefit of the patient, residual risk tends to a small probability, clinical

17、 should be regarded as safety and reliability. The clinical trial data of XXXXConclusionThrough the comparison of the literature search and the analysis of clinical testing, safety and clinical application, and the comparison table 1, we can believe that Unimed sensor is substantive equivalent with

18、the similar product of other companies which have registered in the principle, structure, performance, application. This device in relative benefit of the patient, residual risk tends to a small probability, clinical should be regarded as safety and reliability. In addition, the Unimed sensor has not been occurred any adverse