[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-352517-105":53,"doc-detail-352517-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","iso-14971-compliance-checklist","ISO 14971 compliance checklist","","ISO 14971 compliance checklist outlines core risk management expectations for a medical device organization. It explains how risk management must be embedded across design, development, and post-production activities, including data collection, review, and integration with the quality management system. It also covers management responsibilities, competence and training, the need for a continually maintained risk management plan and risk management file, and the foundation for performing and scoping risk analysis.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/iso-14971-compliance-checklist/352517/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/iso-14971-compliance-checklist/352517.png","ImageObject",442,249,{"name":88,"@type":89},"Elsa","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-22","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What does the checklist require for the risk management process across the medical device lifecycle?","Question",{"text":108,"@type":109},"It requires a documented risk management procedure covering design and development and extending into post-production phases, with production and post-production information collected and reviewed as inputs.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What responsibilities should top management cover?",{"text":113,"@type":109},"Top management must be involved in guidance and effectiveness review, provide adequate resources, ensure competent trained personnel, establish a policy for acceptable risks, and participate in periodic reviews to address weaknesses and improvements.",{"name":115,"@type":106,"acceptedAnswer":116},"What must be included in the risk management plan and risk management file?",{"text":117,"@type":109},"The plan must define the device and lifecycle scope, responsibilities and authorities, criteria for risk acceptability, evaluation methods for residual risk, and planned verification resources; the file must record locations of applicable records with traceability and demonstrate application to each hazard.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},352517,1791329485,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":15,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":79},137455077381,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","ISO 14971  \ncompliance checklist  \n© Qualio—QMS for Life Sciences  \nISO 14971 compliance checklist  \nISO 14971 lays out the core risk management considerations for a medical device organization. It is not an auditable standard which you can get accreditation for, nor is it mandatory to bring your medical device to market. Nevertheless, ISO 14971 offers a useful, comprehensive and industrytrusted framework for embedding GMP into your organization and properly managing the risks connected to your medical device design, development and manufacture. Use this checklist to ensure you meet and apply the demands of the standard.  \n 4. General requirements for risk management  \nItem number Requirement Complete?  \n4.1 Risk management process  \n\n|  | Has the organization ensured the availability of a risk management procedure as part of the design and development of its medical device? | ! |\n| --- | --- | --- |\n|  | Does the risk management process extend into the post-production\u003Cbr>phase (including sterilization, packaging, and labeling where appropriate)? | ! |\n|  | Is production and post-production information and data collected and reviewed as part of the risk management process? | ! |\n|  | Does the organization’s quality management system integrate the risk management process? | ! |\n| 4.2 | Management responsibilities |  |\n|  | Are top management involved in the overall guidance and effectiveness review of the risk management process? | ! |\n|  | Are adequate resources provided for effective risk management\u003Cbr>activities? | ! |\n|  | Are competent individuals trained in the risk management techniques with which they are involved? | ! |\n|  | Has top management established a policy for determining acceptable risks and risk levels? | ! |\n\nDoes top management participate in periodic review of risk management activities to rectify any weaknesses, implement improvements, and adapt to changes?  \n!  \n2  \nISO 14971 compliance checklist  \n\n| 4.3 | Qualification of personnel |  |\n| --- | --- | --- |\n|  | Are only competent people with the necessary knowledge and experience performing risk management tasks: construction, production, intended use determination, application of medical device? | ! |\n|  | Are representatives from various disciplines or functions involved in risk management activity to ensure balanced input? | ! |\n|  | Are records to provide objective evidence of competence and training maintained? | ! |\n|  | Are personnel records properly maintained with confidentiality and security and without duplication? | ! |\n| 4.4 | Risk management plan |  |\n|  | Is a properly organized, maintained plan for continual risk management in place? | ! |\n|  | Does the plan encourage objective and comprehensive evaluation of risks? | ! |\n|  | Is a procedure in place for the development and continued development of the plan? | ! |\n|  | Does the plan contain a thorough description of the pertaining device, including a clear thorough statement of intended use? | ! |\n|  | Does the plan define a scope to establish the baseline on which risk management activities are built, and involve identification of the\u003Cbr>medical device and the phases of its lifecycle? | ! |\n|  | Does the plan clearly allocate responsibilities and authorities to the respective individuals to ensure accountability? | ! |\n|  | Are risk management activities carried out under the plan frequently reviewed by management as an essential responsibility? | ! |\n|  | Are the criteria for risk acceptability defined before beginning risk analysis for effective risk management? | ! |\n|  | Are the evaluation methods and criteria for acceptability of the overall residual risk decided? | ! |\n|  | Is verification activity planned, ensuring that essential resources are available when required? | ! |\n\n3  \nISO 14971 compliance checklist  \nDoes the plan align with the device’s design verification and validation activities?  \n\n|  | Do risk acceptability criteria in the plan derive from your policy of determi","cbCaio7flEDdDghx","https://ap.wps.com/l/cbCaio7flEDdDghx","pdf",1531713,"English","# 4. General requirements for risk management\n## 4.1 Risk management process\n## 4.2 Management responsibilities\n## 4.3 Qualification of personnel\n## 4.4 Risk management plan\n## 4.5 Risk management file\n# 5. Risk analysis\n## 5.1 Risk analysis process\n## 5.2 Intended use/reasonably foreseeable misuse","[{\"question\":\"What does the checklist require for the risk management process across the medical device lifecycle?\",\"answer\":\"It requires a documented risk management procedure covering design and development and extending into post-production phases, with production and post-production information collected and reviewed as inputs.\"},{\"question\":\"What responsibilities should top management cover?\",\"answer\":\"Top management must be involved in guidance and effectiveness review, provide adequate resources, ensure competent trained personnel, establish a policy for acceptable risks, and participate in periodic reviews to address weaknesses and improvements.\"},{\"question\":\"What must be included in the risk management plan and risk management file?\",\"answer\":\"The plan must define the device and lifecycle scope, responsibilities and authorities, criteria for risk acceptability, evaluation methods for residual risk, and planned verification resources; the file must record locations of applicable records with traceability and demonstrate application to each hazard.\"}]","ISO 14971 compliance checklist | PDF",1790100070]