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[영문] 위험관리 보고서(Risk Management Report)

Risk Management Report제품Trade Name:DepartmentName(Position)DateSignaturePrepared byReviewed byReviewed byApproved byRevision HistoryRevision No.Rev. DateRevision Description01Table of Contents1.Introduction1.1 Summary of risk management report1.2 Related references2.Terms and definitions3.Risk management process4.Risk analysis4.1 Risk analysis process4.2 Intended use and identification of characteristics related to the safety of the medical device5.Risk evaluation5.1 Acceptable Criteria5.2 Criteria for risk acceptability5.3 Risk evaluation results before risk control5.4 Analysis for risk evaluation results before risk control6.Risk control6.1 Risk reduction6.2 Risk control option analysis6.3 Implementation of risk control measure(s)6.4 Residual risk evaluation6.5 Risk/benefit analysis6.6 Risks arising from risk control measures6.7 Completeness of risk control7.Requirements for review of risk management activities8.Risk management report8.1 Collection and review activities in production department headAt least once a yearNote) For references of the risk management activities, refer to “1.2 Related references”4.1.3 Roles and responsibilityRoleQualificationResponsibilityR&D DirectorMore than 10 years experience in the development activity,Risk management TrainingcompletedApproval of Risk managementplan / reportProject managerMore than 5 years experience in the development activity,Risk management TrainingcompletedReview risk managementplan/ report,Order the risk management control activity and review the result.QMRMore than 5 years experience in quality Risk management Training completedReview risk management plan/ reportManufacturing managerMore than 3 years experience in manufacturingConsider hazard during manufacturingRisk managementcoordinatorMore than 3 years experience in RA, Risk management Training completedOverall coordinating riskmanagement activities,Record risk management plan and report with teamRisk managementTF TeamDesign background or more than 1years ethat wear or fall off, long term material degradation.ADevice has limited expected service time.A.1.22 To what mechanical forces will the medical device be subjected?Factors that should be considered include whether the forces to which the medical device will be subjected are under the control of the user or controlled by interaction with other persons.Awill be pressed by finger.A.1.23 What determines the lifetime of the medical device?Factors that should be considered include ageing and battery depletion.AA.1.24 Is the medical device intended for single use?Factors that should be considered include: does the medical device self-destruct after use? Is it obvious that the device has been used?Ais a single use device.A.1.25 Is safe decommissioning or disposal of the medical device necessary?Factors that should be considered include the waste products that are generated during the disposal of the medical device itself. For example, does it contain toxic or hazardous material, or is the maf dataKeywordPubMedGoogle Scholar10014.4.5.2 Hit result of adverse event reportSource of dataKeywordMHRAFDA*3MFDA*1Recall*1MAUDE0N/AN/AN/A0N/AN/AN/AN/A42Death: 10Injury: 404N/AN/AN/AN/A3N/AN/AN/A0*1 In FDA’s recall and MAUDE database, it is most efficient to search by device name and product code identified by the FDA, and it is not possible to search by other keyword.*2 In MFDS’s adverse event database, using keywords in English is not efficient, so we used device name defined by MFDS, and manufacturer4.4.6 Data retrieved from non-publish data- 510(k) summary for the equivalent device, K132658,4.4.7 Evaluation of searched listeratureNo.TitleContribution to Side effect124.4.8 Appraisal of adverse eventDatabaseMHRAKeywordSearch Result화면캡쳐 사진Appraisal1N/AKeywordSearch Result화면캡쳐 사진Appraisal1N/ADatabaseU.S. FDA, RecallKeywordFZP (Product code of U.S. FDA)Search Result화면캡쳐 사진Appraisal1We have selected and reviewed 42 casesFDA Determined CauseProduct malfunction (Jaw breaking, Composition sures as the following manners;HazardsA or N/AMethods to provideInformation contentsElectromagnetic energyN/ARadiation energyN/AThermal energyN/AMechanical energyN/ABiologicalALabel,Instruction for use- is single use device, provided in sterile condition through EO sterilization, we have placed relevant symbols on label.- On instructions for use, we have clearly indicated warnings related to biological hazards including not to re-use the device.ChemicalALabel- Symbols are marked on the label.Instructions for use- Description of the symbol in the IFU; Waste disposal of Electric medical equipment; When the life of the product has ended, make sure to dispose of the product after separating it into recyclable materials and wastes to prevent environmental pollution and save resources.BiocompatibilityAInstructions for useInstrucitons for use provide information of expected side effects along with contraindication, warning and caution. The information include side effect due to inadequate bioc6

업무서식| 2021.09.01| 40페이지| 3,000원| 조회(712)

ISO, 위험관리, risk, QC, CE, GMP, FDA, QA, 밸리데이션, 149..

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[영문] 사용자적합성(유저빌리티-Usability) 계획서

[영문] 사용자적합성(유저빌리티-Usability) 계획서입니다.사용자적합성 문서 작성이 어려우니 참고하면 좋을것입니다.

업무서식| 2021.09.01| 15페이지| 2,000원| 조회(346)

ISO, 사용자, CE, GMP, FDA, 적합성, MDD, MDR, 13485

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[영문] PMCF 계획서 평가A+최고예요

Post Market Clinical Follow-up Planfor제품Trade Name:Document no:DepartmentNameDateSignaturePrepared byReviewed byApproved by로고주소31094, Rm#, KoreaReference documentsThe PMCF activities shall be implemented with the provisions of reference documents below.MDDDEV 2.12.2, Guidelines on post market clinical follow-upMDDDEV 2.7.1, Clinical evaluation: a guide for manufacturers and notified bodiesCouncil Directive 93/42/EEC as amended by Directive 2007/47 /ECEuropean Medical Device Vigilance System (MEDDEV 2.12/1)MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan TemplateResponsibility and AuthorityQuality Management department:Collect information such as Literatures, Market feedback (Clinical follow-up and Satisfaction questionnaire, Adverse event or Recall)Prepare Post Market Clinical Follow-up report at least once a yearQuality Management representative:Review the Post Market Clinical Follow-up reportTop management:Approve the Post Market Clinical Follow-up reportDevice information:Namere:Exclusion:Exclude data generated by usingDevice with different intended use.Excluded data lack of high-quality objective evidences, such asCase reportAnimal model studyFor search result of each keyword exceeding 50 hits, review summary and title of first 10 articles. If relevant articles continue, review additional 10 articles. After then, review additional 5 articles until there is no relevance between articles of search results and the device under evaluation.Strategies for addressing data duplication between different publications:In case that duplicate data shows different result in device performance or safety, the reason should be analyzed in depth. The results should be described in final clinical evaluation report.Data management practices to ensure data integrity during extraction:Person who prepares the report shall describe used reference standard, value and method. All negative result regarding the device/equivalent device shall be included as well as positive aspects.Repliance with current knowledge and state of art technology; andAt least 15 years of follow-up shall be carried out as the device include implantable part.Criteria applied to risk management processSeverityCategorySeverityCatastrophic5Disorder that requires Serious medical treatmentCritical4Disability that requires professional medical treatmentSerious3Minor injuriesMinor2Disorder that does not require professional medical treatmentNegligible1Temporary discomfort or dissatisfactionProbabilityCategoryProbability (Within 1 year)Frequent5P > 1/500Probable41/1000 < P ≤ 1/500Occasional31/2000 < P ≤ 1/1000Remote21/5000 < P ≤ 1/2000Improbable1P ≤ 1/5000Statistical considerationRational and statistical analysisWe have collected information of known undesired side effects from XX literatures. Total number of patients involved in the studies is XXXX persons. This data will be considered as reference of which we will be comparing occurrence rate of sides effects of the.We will be monitoring total ecific for the type of device or the group of the medical devices the product belongs to) can be indicated together with a description. A pre-specification of what quality and quantity data – based on the risk of the device(s) and the associated accessories – to be collected and analysed shall be included. Any possible evaluation of suitable national public registries with clinical data on the our own device and/or on similar devices could be specified in this section, identifying the expected quantity and quality of data to be gathered and the search protocols to be adopted.PMCF studies planned could be indicated in this section including the design, sample size, the endpoints, the inclusion/exclusion criteria (e.g. extended follow up of patients included in the pre-market clinical investigations, new clinical investigations within the intended use, retrospective studies). In case of implantable devices and class III devices where clinical investigations have not been performed pursualow-up TemplatePMCF plan number:PMCF plan date:PMCF plan version:Revision historyRev.Revision dateDescription of changeRevised bySection A. Manufacturer contact detailsLegal manufacturer name:Address:SRN:Person responsible for regulatory compliance:E-mail:Phone:Fax:Authorised representative (if applicable):Address:Contact person:E-mail:Phone:Fax:Section B. Medical Device description and specificationProduct or trade name:Model and type:General description of the device:Intended purpose:Intended users:Basic UDI-DI:Intended patient population:Medical condition(s):Indications:Contraindications:Warnings:List and description of any variants and/or configurations covered by this plan:List of any accessories covered by this plan:Certificate number (if available):CND code(s):Class:Classification rule:Expected lifetime:Novel product:☐ yes ☐ noNovel related clinical procedure:☐ yes ☐ noExplanation of any novel features:Section C. Activities related to PMCF: general and specific methods and proce1

업무서식| 2021.09.01| 11페이지| 2,000원| 조회(534)

조사, ISO, 임상, CE, MDD, 사후, MDR, 13485, PMCF

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[영문] PMS 계획서(Post Market Surveillance Plan)

의료기기 GMP 및 CE 인증을 유지하기 위해 필수인 PMS 계획서입니다.업무에 도움이 될것이며, 영문으로 작성되어 있습니다.

교육서식| 2021.09.01| 11페이지| 2,000원| 조회(1,126)

생산, ISO, 정보, pms, CE, GMP, FDA, MDD, MDR, 13485

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CSV(컴퓨터시스템 밸리데이션) 문서입니다. 막상 CSV를 진행하려면 뭘 어떻게 해야 할지 어렵습니다. 이 문서는 CSV의 평가항목을 모두 반영하였으며, 담당자가 쉽게 진행할수 있도록 도와줍니다. 고급 문서입니다. 평가A+최고예요

Operational & Performance Qualification ProtocolFor(Vision system), Inc.제목Title6비젼시스템의컴퓨터시스템운전및성능적격성평가실시계획서컴퓨터시스템구분Classification■ New□ Change□Periodical□User requirement specification□Prospective validation□Design qualification□Retrospective validation□Installation qualification□Concurrent validation□Operational qualification□ Re-Validation■Performance qualification□ Etc.목적Purpose6비젼시스템의컴퓨터시스템변경관리에대한운전및성능적격성평가에대한실시계획을수립하고이를문서화하기위하여작성한다대상설비Equipment6비젼시스탬적용제품Product비젼시스템의컴퓨터시스템하드웨어및소프트웨어대상공정Process실시일정(Predicted schedule)시작일Start완료일Finish보고서작성Report비고Remark :N/A1.0 개정내역(Revision History)개정번호(Revision No.)시행일(Effective Date)제정/개정자(Revised by)개정내역(Revision History)2.0 승인(Authorization)작성자(Prepared By)부서(Dept.)직책(Position)이름(Name)서명 / 날짜(Signature / Date)검토자(Reviewed By)부서(Dept.)직책(Position)이름(Name)서명 / 날짜(Signature / Date)승인자(Approved By)부서(Dept.)직책(Position)이름(Name)서명 / 날짜(Signature / Date)3.0 목차(Table of contents)구분(Items)쪽(Page)1.0개정내역(Revision history)2.0승인(Authorization)3.0목차(Table 라일정이조정될수있으 며,본밸리데이션실시에따른일정은해당적격성평가결과보고서에기술한다.10.0 용어의정의(Definition)10.1 컴퓨터시스템(Computerized System): 컴퓨터시스템이란정보의입력, 전자정보처리, 출력을위해사용되는시스템이다. 여기에는설비-하드웨어, 소프트웨어와설비의취급및사용 자가포함된다. 공장실행시스템(MES), 재고시스템, 시험실시스템(LIMS, GC, HPLC 등), 통 계분석보고서및문서작성시스템, 저장시스템(예를들면데이터베이스, 관리프로그램등), 관리및감시기능시스템, 개인용컴퓨터, 소형시스템(예: 칭량또는라벨링시스템), 네트워 크(예: 시스템과의정보보안)를포함한다. 또한, 사무실, 실험실, 공정자동화를위하거나일 반적인정보처리와문서관리를위해컴퓨터시스템을운영하는사용자소프트웨어등이포함 된다.10.2 컴퓨터시스템밸리데이션 (Computerized System Validation): 컴퓨터시스템의자료를 정확하게분석, 관리, 기록하고미리정해진기준에맞게자료를처리한다는것을고도의보증 수준으로검증하고문서화하는밸리데이션으로서기계, 설비, 시스템별로실시하여야한다.10.3 직접영향시스템 (Direct Impact System): 직접영향시스템은제품및공정품질에영향을 줄것이라예상되는시스템이다.10.4 컴퓨터시스템카테고리화 (Computer System Categorization): ISPE GAMP 5 가이드에 서제시된시스템특징에따른컴퓨터시스템밸리데이션대상을설정하고해당시스템의수준 에따른밸리데이션활동을결정하는것이다.10.5 검증(Verification): 소프트웨어생명주기상의각단계에서생성되는산출물이이전단계에서 설정된요구사항을만족하는지를결정하는과정을말한다. 명시된요구사항이충족되었음을시 험과객관적인증거를준비함으로서확인하는것이다.10.6 밸리데이션(Validation): 소프트웨어개발과정에서생성된최종산출물이사용자요구규격을만족하는지를보장하기위한평가과정을말한다. 특별한요구사항으로서특정의도에의한사용이만족됨을보이기위해시험과객관적인증거를준비함으로서확인하는것이다.10.7 폐근시허가된자만이접근할 수있는지확인하고접근이허용되지않은자의접근을차단할수있는지확인하도록한다. 다만사용자의접근허용범위에대해설정되어있지않을경우임의의설정을만들어접근이 차단되는지확인하도록하며, 실제공정전까지사용자의접근권한을구분하여등급을설정할 수있도록한다.12.5.4 백업(Back-Up)제어및모니터링된데이터는기록을통해파일로저장되므로주기적인데이터의백업이 가능한지확인하도록한다. 또한초기에공급자가제공한소프트웨어가백업되어있는지 확인하여문제가발생할경우백업된소프트웨어로재설치가되는지확인한다. 다만, 현재 설치된장비/설비는사용중이므로소프트웨어및데이터의백업기능만을확인하도록하며, 재설치기능은확인하지않는다. 재설치는추후시스템이변경될경우에실시하는것으로 한다.12.5.5 Power Failure Recovery본시스템에는별도의비상전원장치가설치되지않으나전기공급에문제가발생할경우에도 시스템이중단되지않고이상없이안정적으로가동되고소프트웨어및데이터의저장및 기록에문제가없음을확인할필요가있다. 이에본격성평가에서는전원을강제차단하고 복구한후응용소프트웨어의운전, 데이터의기록, 주요인자의설정값에이상이없는지확인 하여 Power Failure Recovery 기능의적절성을확인하도록한다.12.5.6 Audit Trail현재설치되어운용중인장비/설비의제어시시스템의중요인자(보안, 시스템의데이터등) 가 변경될경우변경된날짜, 시간, 접속된사용자및변경사유가기록되어변경사항을추적 감사할수있는지확인하도록한다. 또한 Audit Trail 데이터의판독및출력이가능한지 확인하도록한다.13.0 시험항목및절자(Test Item & Procedure)13.1 운전및성능적격성평가준비상태확인시험( )13.1.1 목적13.1.1.1 적격성평가실시계획서작성자(또는검토자)는승인된해당실시계획서로적격성평가실시자및확인자를대상으로교육을실시하는데목적이있다.13.1.1.2 교육이완료된실시자및확인자의서명및 Initial을등록하여자격이부여된자(Qualified Person)가적격성평가를실시하도록하는데목적이있다.13.1.1.3 적격성평가에사용할측정장비(Test Equipment다.13.2.5.1.13 등록정보(또는속성)를연후테스트페이지인쇄를눌러인자상태를확인한다.13.2.5.1.14 프린터자체진단페이지검사기능이있을경우매뉴얼에따라절차를수행하여프린터를자체진단한후진단페이지를인쇄한다.13.2.5.1.15 인쇄된테스트페인지및진단페이지는해당기록양식에첨부하도록한다.13.2.6 허용기준13.2.6.1 시스템의가동에문제가없어야한다.13.2.6.2 모니터의색상에이상이없어야한다.13.2.6.3 소프트웨어의구동시모니터의떨림이나글자가깨지는현상이없어야한다.13.2.6.4 프린터의인자상태에이상이없어야한다.13.2.6.5 소프트웨어의데이터출력에문제가없어야한다.13.2.7 관련양식No.Test itemTestsheet No.1운전환경적격성확인시험13.3 경고,알람및비상기능확인시험 ( )13.3.1 목적경고, 알람및비상기능이시각또는청각적으로정상작동되는지확인하기위함이다.13.3.2 적용범위운전중경고, 알람및비상기능확인에적용한다.13.3.3 시험방법및장비육안확인13.3.4 참조문서및자료장비SOP, 경보알람리스트13.3.5 절차13.3.5.1 장비SOP에따라장비를가동시킨다.13.3.5.2 점검문서에따라비상정지스위치의동작여부에대한테스트를실시하고결과를기록한다.13.3.5.3 점검문서에따라주요경보알람이시각또는청각적으로이상없이작동하는지확인한다.13.3.5.4 경고및알람을강제로발생하지않아야하며,알람을발생할수없을경우기존에발생한알람의내역을통해추적이가능한지확인한다.13.3.5.5 기록양식에결과를기록하고확인에사용된문서가있을경우첨부한다.13.3.6 허용기준점검기록양식의점검항목및허용기준을만족하여야한다.13.3.7 관련양식No.Test itemTestsheet No.1경고,알람및비상기능확인시험13.4 Power Failure Recovery 확인시험( )13.4.1 목적시스템에공급되는전원차단및복구시응용소프트웨어의운전, 데이터저장, 운전인자설정값에이상이없는지확인하기위함이다.13.4.2 적용범위전기의안정적인공급을위해사용하는무정전전원장치에대해적용한다.13.4.3 시험방법및장비육안확인13.4.4 참인시험( )13.8.1 목적본시스템에설치된소프트웨어및데이터의문제발생시를대비하여데이터및프로그램의백업및복구절차에따라소프트웨어및데이터를백업하였는지확인하기위하여실시한다.13.8.2 적용범위본시스템에설치된소프트웨어및데이터의백업관리에대해적용한다.13.8.3 시험방법및장비육안확인13.8.4 참조문서및자료기능및디자인규격서, 시스템매뉴얼13.8.5 절차13.8.5.1 소프트웨어백업(Backup) 관리의확인13.8.5.1.1 컴퓨터시스템에설치되어있는응용프로그램에대해관리책임부서를확인한다.13.8.5.1.2 설치된응용프로그램을컴퓨터시스템_제어판_프로그램추가/제거에서확인한다.13.8.5.1.3 확인된응용프로그램이백업되었는지, 백업되어보관되고있는장소는어디인지확인한다.13.8.5.1.4 설치된응용프로그램과백업된응용프로그램이일치하는지확인한다.13.8.5.1.5 확인결과를해당기록양식에기록한다.13.8.5.2 데이터백업(Backup) 관리의확인13.8.5.2.1 컴퓨터시스템에서백업이필요한응용프로그램의데이터를확인한다.13.8.5.2.2 데이터가백업된저장위치가컴퓨터시스템내부또는외부인지확인한다.13.8.5.2.3 별도의장소에데이터를백업한경우데이터의백업관리책임부서를확인하고, 저장된데이터및 백업된데이터의파일명및보관장소를확인한다.13.8.5.2.4 기록된데이터와백업된데이터가일치하는지확인한다. 단데이터가백업된시점이틀릴경우데이터가추가저장되어이전에백업된데이터와일치하지않을수있다.13.8.5.2.5 확인결과를해당기록양식에기록한다.13.8.6 허용기준13.8.6.1 소프트웨어백업(Backup) 관리의확인13.8.6.1.1 시스템에설치되어있는응용프로그램에대해관리책임부서가있어야한다.13.8.6.1.2 스템에설치된응용프로그램은설치된프로그램에이상이발생하였을경우복구할수있도록백업되어있어야한다.13.8.6.2 데이터백업(Backup) 관리의확인시스템에서백업이필요한중요데이터는컴퓨터의내부및외부에안전하게백업되어있어야하며, 컴퓨터시스템에이상이발생하여데이터가손상되었을경우데이터를복구할수있어야한다.13.8.7 관련양식No.Test ite다.

사규/규정| 2021.01.22| 36페이지| 10,000원| 조회(1,053)

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