[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-352518-105":53,"doc-detail-352518-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","understanding-integrated-risk-management-for-medical-devices","Understanding Integrated Risk Management for Medical Devices","","A whitepaper explains integrated risk management for medical devices, linking ISO 14971 risk-based thinking to product development and organizational execution. It defines core terms such as harm, hazard, hazardous situation, risk, safety, severity, and the probability–severity model. The paper details how risk analysis, assessment, evaluation, control, and estimation work together, including the expected order of risk control options. It also emphasizes end-to-end traceability to strengthen risk handling and audit readiness.",{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/understanding-integrated-risk-management-for-medical-devices/352518/",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/understanding-integrated-risk-management-for-medical-devices/352518.png","ImageObject",442,249,{"name":88,"@type":89},"4398046744996","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-29","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":25},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the role of ISO 14971 in medical device risk management?","Question",{"text":108,"@type":109},"ISO 14971 provides a structured approach intended to support medical device manufacturers in identifying and managing risk-related requirements, while recognizing that different approaches may vary.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How are risk and severity defined under ISO 14971 terminology?",{"text":113,"@type":109},"Risk combines the probability of harm and the severity of harm. Severity measures the possible harmful consequences a hazard could cause.",{"name":115,"@type":106,"acceptedAnswer":116},"What order of risk control options does ISO 14971 expect?",{"text":117,"@type":109},"The expected order is: design safety into the product, establish protective measures, then provide safety information.","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},352518,1791745021,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":60,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":129,"file_id":130,"file_url":131,"file_type":132,"file_size":133,"view_count":25,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":8,"language":134,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":135,"faqs":136,"seo_title":137,"seo_description":61,"update_tm":138,"read_time":79},4398046744996,"WHITEPAPER  \nUnderstanding Integrated Risk Management for Medical Devices  \nKnowledge on best practices, how to integrate risk-based thinking into product development cycles, and the importance of having end-to-end traceability to improve risk management, shared by industry and solution experts.  \nUnderstanding Integrated Risk Management for Medical Devices  \nA level of risk exists with all medical devices, no matter how simple they are. Companies developing medical devices are constantly considering who (or what environment, facility, etc.) could potentially be hurt by a device so they can help reduce risk and meet regulatory requirements. Risk management in the context of ISO 14971 is designed to support medical device manufacturers with these tasks—but not all approaches are equal.  \nThe amount of time it takes to manage risks, connect specific risks to specific requirement tasks, and pull together required documents to respond to an audit varies slightly depending on the approach. The risk management process is an integrated process that not only includes teams in product development, quality, but also many other parts of an organization.  \nThis whitepaper taps into the knowledge of industry and solution experts to uncover best practices, how to integrate risk-based thinking into product development cycles, and the importance of having end-toend traceability to improve risk management.  \nBefore we dig into integrated risk management, let’s first define some key terms.  \n Risk Management Terms According to ISO 14971  \nHarm  \nHazard  \nHazardous Situation  \nRisk  \nHarm occurs when people are injured physically or their health is compromised or when property or the environment is damaged.  \nA hazard is a potential source of harm. Annex E.2 categorizes hazards in the following way: energy hazards, chemical hazards, biological hazards, operational hazards, and informational hazards.  \nA hazardous situation occurs when people are exposed to a hazard or when property or the environment is threatened. A hazardous situation exists when a vulnerable entity is exposed to a hazard.  \nAccording to ISO 14971, the concept of risk combines two variables: the probability of harm and the severity of harm.  \nFor example, if a particular hazardous situation is very likely to cause harm and would be very harmful if it actually occurred, then it would be a high risk situation. Conversely, if it’s very unlikely to cause harm and would be only slightly harmful if it actually occurred, then it would be a trivial risk.  \n[jamasoftware.com](jamasoftware.com) Understanding Integrated Risk Management for Medical Devices | 2  \n\n| Risk Analysis\u003Cbr>Risk Assessment\u003Cbr>Risk Evaluation\u003Cbr>Risk Control\u003Cbr>Risk Estimation\u003Cbr>Risk Management\u003Cbr>Safety\u003Cbr>Severity | Risk analysis is a systematic process that is used to identify hazards and to estimate risk. It includes an examination of every reasonably foreseeable sequence or combination of events that could produce a hazardous situation and cause harm.\u003Cbr>Risk assessment is a process that is, in turn, made up of two interconnected processes: risk analysis and risk evaluation.\u003Cbr>Risk evaluation is a process that is used to examine the estimated risk for each hazardous situation and then to use risk acceptability criteria to determine whether or not the estimated risk is acceptable and to decide if risk reduction is required.\u003Cbr>Risk control is a process that is used to consider risk control options and to select and implement risk control measures that will reduce risk or maintain risk within specified levels. ISO 14971 expects you to consider the following risk control options and, if possible, to apply them in the following order:\u003Cbr>1. Design safety into the product.\u003Cbr>2. Establish protective measures.\u003Cbr>3. Provide safety information.\u003Cbr>Risk estimation is a process that is used to assign qualitative or quantitative probability values and severity values to each hazardous situation. These values are then ","cbCaisq11eV3o0oI","https://ap.wps.com/l/cbCaisq11eV3o0oI","pdf",4251309,"English","# Risk Management Terms According to ISO 14971\n## Harm, Hazard, and Hazardous Situation\n## Risk, Probability, and Severity\n# Risk Analysis, Assessment, Evaluation, Control, and Estimation\n## Risk Analysis\n## Risk Assessment\n## Risk Evaluation and Acceptability\n## Risk Control Options\n# The Risk Management Process","[{\"question\":\"What is the role of ISO 14971 in medical device risk management?\",\"answer\":\"ISO 14971 provides a structured approach intended to support medical device manufacturers in identifying and managing risk-related requirements, while recognizing that different approaches may vary.\"},{\"question\":\"How are risk and severity defined under ISO 14971 terminology?\",\"answer\":\"Risk combines the probability of harm and the severity of harm. Severity measures the possible harmful consequences a hazard could cause.\"},{\"question\":\"What order of risk control options does ISO 14971 expect?\",\"answer\":\"The expected order is: design safety into the product, establish protective measures, then provide safety information.\"}]","Understanding Integrated Risk Management for Medical Devices | PDF",1790100074]