{"id":10235,"date":"2022-10-05T09:29:46","date_gmt":"2022-10-05T09:29:46","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=10235"},"modified":"2022-10-05T09:29:46","modified_gmt":"2022-10-05T09:29:46","slug":"risk-management-medical-devices-manage-mitigate","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/","title":{"rendered":"Risk Management in Medical Devices: Evaluation, Mitigation &#038; Management"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabla de contenidos<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f366e595617\" aria-label=\"Tabla de contenidos\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f366e595617\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/#Workflow_-_Risk_Management_in_Medical_Devices\" title=\"Workflow &#8211; Risk Management in Medical Devices\">Workflow &#8211; Risk Management in Medical Devices<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/#The_Role_of_AAMI_Certifications_to_Follow_the_ISO_Standards\" title=\"The Role of AAMI Certifications (to Follow the ISO Standards)\">The Role of AAMI Certifications (to Follow the ISO Standards)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/#What_is_ISO_14971_2019_and_Its_Significance\" title=\"What is ISO 14971:2019 and Its Significance?\">What is ISO 14971:2019 and Its Significance?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/#How_Can_Kolabtree_Freelancers_Guide_You_Through_Medical_Device_Risk_Management\" title=\"How Can Kolabtree Freelancers Guide You Through Medical Device Risk Management?\">How Can Kolabtree Freelancers Guide You Through Medical Device Risk Management?<\/a><\/li><\/ul><\/nav><\/div>\n<p>Ensuring risk management in<span style=\"font-weight: 400;\">\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-devices\">Medical device<\/a><\/span><span style=\"font-weight: 400;\"> is a continuous process, and medical device manufacturers have a difficult task at hand while ensuring that their products (be it instruments, apparatus or materials) are safe for continued use in or by humans (in patients\/ by users). <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Here, Kolabtree&#8217;s <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/risk-management\">cient\u00edfico aut\u00f3nomo<\/a> <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/aditi-kandlur\">Aditi Kandlur<\/a> elaborates on how ensuring product safety and efficiency comes through a process of <\/span><a href=\"https:\/\/www.wipro.com\/medical-devices\/basic-principles-of-risk-management-for-medical-device-design\/\"><span style=\"font-weight: 400;\">risk management<\/span><\/a> in medical devices<span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hazard or <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/\"><span style=\"font-weight: 400;\">Gesti\u00f3n de riesgos<\/span><\/a><span style=\"font-weight: 400;\"> in medical devices involves identifying, evaluating and establishing measures to prevent hazards by the product, especially during the design and development of medical devices across industries such as <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/ai-trends-medtech-healthcare-whitepaper-kolabtree\/\"><span style=\"font-weight: 400;\">medtech<\/span><\/a><span style=\"font-weight: 400;\"> y <a href=\"https:\/\/www.kolabtree.com\/blog\/es\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">salud<\/a>. The higher the concern, the stronger the measures that must be undertaken by the manufacturer, with the help of competent <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/risk-management\"><span style=\"font-weight: 400;\">risk management experts<\/span><\/a><span style=\"font-weight: 400;\"> y <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\"><span style=\"font-weight: 400;\">regulatory consultants,<\/span><\/a><span style=\"font-weight: 400;\"> to bring it to an acceptable range.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Workflow_-_Risk_Management_in_Medical_Devices\"><\/span>Workflow &#8211; Risk Management in Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Risk management is a compulsory requirement worldwide. The global markets have different specifications of compliance based on geographical regions. Canada, Australia, Japan, Brazil and other major global markets refer to <\/span><a href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\"><span style=\"font-weight: 400;\">ISO 13485:2016<\/span><\/a><span style=\"font-weight: 400;\">, which gives particular focus on the design, production, installation and servicing of medical devices (while the latest clauses show increased attention towards risk management in the supply chain).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The US FDA and the EMA, through their quality management regulations- 21 CFR Part 820 and MDR 2017\/745, respectively, direct manufacturers to focus on risk management. Under the MDR, <\/span><a href=\"https:\/\/www.medical-device-regulation.eu\/mdr-article-10-general-obligations-of-manufacturers\/\"><span style=\"font-weight: 400;\">Article 10\/2<\/span><\/a><span style=\"font-weight: 400;\"> states \u201cthe manufacturers must establish, document, implement and maintain a product safety risk management system\u201d throughout the lifecycle of their medical device\/product. The detailed requirements are in Annex I Chapter I, clauses 2-9. The MDR is in alignment with EN ISO 14971:2019 and EN ISO 13485:2016.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Establishing the risk-benefit analysis through a risk analysis plan and a risk analysis report, as per these two ISO standards, allows for compliance with the MDR from the manufacturer\u2019s end.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The medical device <\/span><a href=\"https:\/\/www.greenlight.guru\/blog\/iso-14971-risk-management#summary\"><span style=\"font-weight: 400;\">Gesti\u00f3n de riesgos<\/span><\/a><span style=\"font-weight: 400;\"> lifecycle must include planning, risk analysis, risk evaluation, setting up of risk controls, establishing overall residual risk acceptability, review, production and post-production information collection as well as analysis. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">ISO 14971 permits many approaches to performing risk management. It is, however, the company\u2019s choice and decision to take up the option that best fits its culture, requirements and business goals. A few <\/span><a href=\"https:\/\/www.meddeviceonline.com\/doc\/the-what-why-when-and-how-of-risk-management-for-medical-device-manufacturers-0001\"><span style=\"font-weight: 400;\">risk management methodologies<\/span><\/a><span style=\"font-weight: 400;\"> that are followed include: <\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8211; a top-down approach, Fault tree analysis (FTA) <\/span> <span style=\"font-weight: 400;\">&#8211; bottom-up approaches such as Failure modes and effects analysis (FMEA) and failure modes, effects, and criticality analysis (FMECA). <\/span><\/p>\n<p><a href=\"https:\/\/www.mpo-mag.com\/contents\/view_online-exclusives\/2020-08-24\/areas-to-consider-in-medical-device-risk-management\/\"><span style=\"font-weight: 400;\">The final steps of identifying hazards<\/span><\/a><span style=\"font-weight: 400;\"> associated with the medical device include <\/span><a href=\"https:\/\/www.mindflowdesign.com\/insights\/medical-device-risk-management-plan-starter-guide\/\"><span style=\"font-weight: 400;\">determining the areas of risk<\/span><\/a><span style=\"font-weight: 400;\"> while reviewing the sections of potential hazards mentioned in table C.1 in Annex C of ISO 14971:2019 (including thermal energy, electromagnetic energy, mechanical energy, biological and chemical hazards). Post identification of risks, their level is evaluated to see which comes under the acceptable risk category. To perform the classification of acceptable risks vs. non-acceptable risks, a risk evaluation matrix is drawn.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">After the additional brackets of hazards and hazardous situations are identified while referring to the <\/span><a href=\"https:\/\/www.iso.org\/standard\/65529.html\"><span style=\"font-weight: 400;\">IEC 60601<\/span><\/a><span style=\"font-weight: 400;\">, these lists should be updated to contain all possible hazards\/situations and they must align with the items in table C.1. The manufacturer should also enlist explanations regarding whether it is concluded that a particular hazard is relevant to their medical device\/product or not. The IEC 60601-1, Medical electrical equipment \u2013 Part 1 was one of the first of its kind standard made for medical devices in 1970. This has turned out to be an internationally recognized standard that covers the basic safety and functionality of medical devices. The most recent version was released in 2020.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Additionally, medical device risk management policies need to be incorporated across all the stages of medical device design and development, and should be also associated with design control. A lot of importance is given to the complete lifecycle of medical device risk management since, if it is not executed correctly, it can affect the resources of the company- such as the budget and time to market. All resources would have to be deployed to redesign, redevelop and retest the device\/product, which might result in losses to the company. All this points to the <\/span><a href=\"https:\/\/sterlingmedicaldevices.com\/services\/fda-ce-medical-device-regulatory-compliance-consulting-services\/medical-device-risk-management\/\"><span style=\"font-weight: 400;\">significance of the risk management lifecycle<\/span><\/a><span style=\"font-weight: 400;\"> being performed diligently.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Criteria are defined during the risk identification process. If a risk\/hazard\/hazardous situation identified during the risk management process for medical devices is beyond the defined criteria, then the situation would demand a risk mitigation plan to be set up. Hazard\/risk analysis early on can be used to check which standards would best suit the device. Initial assessments and management of risks can be based on the framework of the <\/span><a href=\"https:\/\/www.meddeviceonline.com\/doc\/iso-harnessing-preliminary-hazard-analysis-pha-to-develop-safer-medical-devices-0001#:~:text=ISO%2014971%3A%20Harnessing%20Preliminary%20Hazard%20Analysis%20%28PHA%29%20To,International%20Standard%20for%20Risk%20Management%20of%20Medical%20Devices.\"><span style=\"font-weight: 400;\">Preliminary Hazard Analysis (PHA)<\/span><\/a><span style=\"font-weight: 400;\"> under the ISO 14971 standard. The PHA envelops risk analysis and evaluation to classify the risk levels. The PHA comprises lists of risks\/hazards\/ hazardous situations based on the medical devices\u2019 construction\/raw material, interfaces- human with device or manual, the usage environments or use cases among others.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Risk can also stem from supply chain vulnerabilities- longer lead generation times, higher levels of cyclicity etc, this would in turn mean a delay in receiving materials and an imbalance in the stock material inventory maintenance and hence impact business continuity. In these situations, the <\/span><a href=\"https:\/\/quasar-med.com\/knowledge_center\/medical-device-risk-mitigation\/\"><span style=\"font-weight: 400;\">optimal risk mitigation<\/span><\/a><span style=\"font-weight: 400;\"> strategy would be to reduce reliance on single-sourced components. There is increased stress on maintaining flexibility in operations in the supply chain to enable business critical options to move as planned. This can mean that the manufacturers can make use of multiple sources\/plants to ensure an uninterrupted production flow even in the times of crises.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Risk management of medical devices is innately a probabilistic field. Companies must focus on unpredictable crises and have resilient strategies in the supply chain to back them up. These strategies are to be regularly checked and updated using quality management systems and regular audits to be ever ready to face a disruptive crisis. Apart from the supply chain, the company must also look into potential failures in the production process as well. Here, they must look into the product\u2019s efficacy, reliability and safety. The future development of the product relies on the knowledge gained from risk assessments.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Role_of_AAMI_Certifications_to_Follow_the_ISO_Standards\"><\/span>The Role of AAMI Certifications (to Follow the ISO Standards)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">El <\/span><a href=\"https:\/\/www.aami.org\/standards\/\"><span style=\"font-weight: 400;\">Association for the Advancement of Medical Instrumentation<\/span><\/a><span style=\"font-weight: 400;\"> is an ANSI accredited (American National Standards Institute) standards development institution. They play a major role in developing the National standards in the US to meet the basic and essential level of openness, harmony, consensus, and due process set by the ANSI. The AAMI oversees several international technical committees of the ISO (International Organization for Standardization)as well as the IEC (International Electrotechnical Commission (IEC).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If the target market for the company to sell the medical device is the US, it must comply with FDA regulations. Medical devices that were designed based on other standards including ISO have a higher risk of not being approved by the FDA. This is due to the FDA having adaptations from international and regional standards, one such standard applicable to medical devices-<\/span><\/p>\n<p><a href=\"https:\/\/array.aami.org\/content\/news\/focus-risk-management-update-risk-management-standards#:~:text=For%20more%20than%2020%20years%2C%20ANSI%2FAAMI%2FISO%2014971%2C%20Medical,manufacturers%20and%20regulatory%20authorities%20to%20prevent%20patient%20harm.\"><span style=\"font-weight: 400;\">ANSI\/AAMI\/ISO 14971<\/span><\/a><span style=\"font-weight: 400;\"> has been a harmonized standard followed by regulatory bodies and manufacturers. The aim of such regulations is supporting the production of medical devices\/products that give assurance of the patient\u2019s safety.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_ISO_14971_2019_and_Its_Significance\"><\/span>What is ISO 14971:2019 and Its Significance?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/www.cognidox.com\/blog\/medical-device-iso-149712019\"><span style=\"font-weight: 400;\">ISO 14971:2019<\/span><\/a><span style=\"font-weight: 400;\"> is the latest edition of global regulations for medical devices to guide manufacturers in the process of risk\/hazard identification, risk assessments and finally, establish control measures. While it also ensures the company is able to monitor the effectiveness of the risk management protocols set in place.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">El <\/span><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"><span style=\"font-weight: 400;\">ISO 14971<\/span><\/a><span style=\"font-weight: 400;\"> standards apply throughout the product life cycle, including the post-production phase. It also is in line with the European Union Medical Device Regulation (EU MDR) and <\/span><i><span style=\"font-weight: 400;\">In Vitro<\/span><\/i><span style=\"font-weight: 400;\"> Diagnostic Regulation (IVDR). The regulations have included a definition that is more specific and focused on predictable misuse of the product. The broad inclusion of such \u201creasonably foreseeable\u201d risks applies to professional and lay users of the medical device\/product.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ISO 14971 defines a standard process for identifying risks associated with medical devices at all stages of their life cycle. In all cases, the goal is to analyze, evaluate, control, and monitor the risks associated with each lifecycle stage. The ISO standard is shorter than its predecessors. Many of the annexes from the 2007 version have been shifted into guidance document <\/span><a href=\"https:\/\/www.iso.org\/standard\/74437.html\"><span style=\"font-weight: 400;\">ISO\/TR 24971:2020<\/span><\/a><span style=\"font-weight: 400;\">, which provides support for implementing risk management.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0This new edition comprises ten clauses and three annexes.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If the medical device company is considering the European Union as the target market to sell, there are similar standards that have been adopted from the ISO by the European Committee for Standardization (CEN) and from the IEC by the European Committee for Electrotechnical Standardization (CENELEC).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CEN has modified the device as per requirement from ISO and written with an \u201cEN\u201d prefix, such as e.g.:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EN ISO 14971:2019, Medical devices \u2014 Application of risk management to medical devices<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">EN ISO 13485:2016, Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"How_Can_Kolabtree_Freelancers_Guide_You_Through_Medical_Device_Risk_Management\"><\/span><b>How Can Kolabtree Freelancers Guide You Through Medical Device Risk Management?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The global rise in the market for medical devices has grown with an innate complexity to ensure their safe and efficient use and functioning of them. This has led to the formulation of standards and regulations that differ across various regions and countries. Manufacturers would need to consult risk management experts to ensure compliance with the regulations based on the target market geographies. This would be key in gaining access to a broader range of international markets.<\/span><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-prepare-a-risk-management-plan-rmp-an-essential-guide\/\"><span style=\"font-weight: 400;\">Efficient medical device risk management<\/span><\/a><span style=\"font-weight: 400;\"> is one where it is applied early on and throughout the process of design and development. Throughout the process even after release into the market, feedback helps in modifying steps in the design and development of the medical device. There is always a chance that at any stage risks\/hazards can come up, so <a href=\"https:\/\/www.mindflowdesign.com\/insights\/medical-device-risk-management-plan-starter-guide\/\">putting together an efficient risk management panel<\/a><\/span><span style=\"font-weight: 400;\">\u00a0would be essential.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Here\u2019s where platforms like<\/span><a href=\"https:\/\/www.kolabtree.com\/\"><span style=\"font-weight: 400;\"> Kolabtree<\/span><\/a><span style=\"font-weight: 400;\"> can provide cost-effective solutions, helping businesses tap into independent <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/risk-management\"><span style=\"font-weight: 400;\">risk management experts<\/span><\/a><span style=\"font-weight: 400;\"> available for on-demand consulting. This helps firms hire these experts for short-term consulting, make sure foolproof risk management solutions are implemented, and consult them as and when their expertise is required.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">These experts help companies assess the potential risks pertaining to the medical device and later decide on what risk control protocols are to be implemented. A vital move for the company would be to employ efficient and competent individuals from varied disciplines who understand each aspect of the medical device \u2014 from its construction to its proper usage scenarios.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The panel would need a mosaic representation from various departments- the <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-affairs\"><span style=\"font-weight: 400;\">normativa <\/span><\/a><span style=\"font-weight: 400;\">department, quality control, <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/engineering\"><span style=\"font-weight: 400;\">engineering<\/span><\/a><span style=\"font-weight: 400;\">, manufacturing, human factors engineering, marketing and also<\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/risk-management\"> risk analysts<\/a>.<\/span><\/p>\n<p><b>Referencias<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.wipro.com\/medical-devices\/basic-principles-of-risk-management-for-medical-device-design\/\"><span style=\"font-weight: 400;\">Medical Device Design Risk Management Basic Principles\u200a\u2014\u200aWipro<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/iso-13485-medical-devices.html\"><span style=\"font-weight: 400;\">ISO\u200a\u2014\u200aISO 13485\u200a\u2014\u200aMedical devices<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Risk_assessment\"><span style=\"font-weight: 400;\">Medical Device Technical File Checklist: The Ultimate Guide (kolabtree.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.greenlight.guru\/blog\/iso-14971-risk-management#summary\"><span style=\"font-weight: 400;\">ISO 14971 Risk Management for Medical Devices: The Definitive Guide (greenlight.guru)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.meddeviceonline.com\/doc\/the-what-why-when-and-how-of-risk-management-for-medical-device-manufacturers-0001\"><span style=\"font-weight: 400;\">The What Why When And How Of Risk Management For Medical Device Manufacturers (meddeviceonline.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.mpo-mag.com\/contents\/view_online-exclusives\/2020-08-24\/areas-to-consider-in-medical-device-risk-management\/\"><span style=\"font-weight: 400;\">Areas To Consider In Medical Device Risk Management | Medical Product Outsourcing (mpo-mag.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.mindflowdesign.com\/insights\/medical-device-risk-management-plan-starter-guide\/\"><span style=\"font-weight: 400;\">How to Start a Medical Device Risk Management Plan (mindflowdesign.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/65529.html\"><span style=\"font-weight: 400;\">ISO &#8211; IEC 60601-1-11:2015 &#8211; Medical electrical equipment \u2014 Part 1-11: General requirements for basic safety and essential performance \u2014 Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/sterlingmedicaldevices.com\/services\/fda-ce-medical-device-regulatory-compliance-consulting-services\/medical-device-risk-management\/\"><span style=\"font-weight: 400;\">Medical Device Risk Management (sterlingmedicaldevices.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.meddeviceonline.com\/doc\/iso-harnessing-preliminary-hazard-analysis-pha-to-develop-safer-medical-devices-0001#:~:text=ISO%2014971%3A%20Harnessing%20Preliminary%20Hazard%20Analysis%20%28PHA%29%20To,International%20Standard%20for%20Risk%20Management%20of%20Medical%20Devices.\"><span style=\"font-weight: 400;\">ISO 14971 Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices (meddeviceonline.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/\"><span style=\"font-weight: 400;\">Medical Device Design: The Essential, Step-by-Step Guide (kolabtree.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/quasar-med.com\/knowledge_center\/medical-device-risk-mitigation\/\"><span style=\"font-weight: 400;\">Creating a Medical Device Risk Mitigation Strategy (quasar-med.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.aami.org\/standards\/\"><span style=\"font-weight: 400;\">AAMI Standards Development | AAMI<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/array.aami.org\/content\/news\/focus-risk-management-update-risk-management-standards#:~:text=For%20more%20than%2020%20years%2C%20ANSI%2FAAMI%2FISO%2014971%2C%20Medical,manufacturers%20and%20regulatory%20authorities%20to%20prevent%20patient%20harm.\"><span style=\"font-weight: 400;\">ARRAY | News (aami.org)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.cognidox.com\/blog\/medical-device-iso-149712019\"><span style=\"font-weight: 400;\">What&#8217;s new for medical device manufacturers in iso 14971:2019? (cognidox.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/72704.html\"><span style=\"font-weight: 400;\">ISO &#8211; ISO 14971:2019 &#8211; Medical devices \u2014 Application of risk management to medical devices<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.iso.org\/standard\/74437.html\"><span style=\"font-weight: 400;\">ISO &#8211; ISO\/TR 24971:2020 &#8211; Medical devices \u2014 Guidance on the application of ISO 14971<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.mindflowdesign.com\/insights\/medical-device-risk-management-plan-starter-guide\/\"><span style=\"font-weight: 400;\">How to Start a Medical Device Risk Management Plan (mindflowdesign.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/medicaldevicehq.com\/articles\/performing-medical-device-risk-evaluation\/\"><span style=\"font-weight: 400;\">Performing medical device risk evaluation &#8211; Medical Device HQ<\/span><\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Ensuring risk management in\u00a0Medical device is a continuous process, and medical device manufacturers have a difficult task at hand while ensuring that their products (be it instruments, apparatus or materials) are safe for continued use in or by humans (in patients\/ by users). Here, Kolabtree&#8217;s freelance scientist Aditi Kandlur elaborates on how ensuring product safety<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/\" title=\"Leer m\u00e1s\">Leer m\u00e1s<\/a><\/div>","protected":false},"author":605,"featured_media":10236,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[317,540],"tags":[474,482,714,715],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Risk Management in Medical Devices: Evaluation, Mitigation &amp; Management -<\/title>\n<meta name=\"description\" content=\"Risk management in medical devices: Kolabtree&#039;s guide on how ensuring product safety and efficiency comes via a process of risk management.\u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risk Management in Medical Devices: Evaluation, Mitigation &amp; Management\" \/>\n<meta property=\"og:description\" content=\"Risk management in medical devices: Kolabtree&#039;s guide on how ensuring product safety and efficiency comes via a process of risk management.\u00a0\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2022-10-05T09:29:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/10\/shutterstock_146147621.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Naren Madan\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Naren Madan\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Risk Management in Medical Devices: Evaluation, Mitigation & Management -","description":"Risk management in medical devices: Kolabtree's guide on how ensuring product safety and efficiency comes via a process of risk management.\u00a0","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/","og_locale":"es_ES","og_type":"article","og_title":"Risk Management in Medical Devices: Evaluation, Mitigation & Management","og_description":"Risk management in medical devices: Kolabtree's guide on how ensuring product safety and efficiency comes via a process of risk management.\u00a0","og_url":"https:\/\/www.kolabtree.com\/blog\/es\/risk-management-medical-devices-manage-mitigate\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2022-10-05T09:29:46+00:00","og_image":[{"width":1000,"height":667,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/10\/shutterstock_146147621.jpg","type":"image\/jpeg"}],"author":"Naren Madan","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"Escrito por":"Naren Madan","Tiempo de lectura":"9 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/risk-management-medical-devices-manage-mitigate\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/risk-management-medical-devices-manage-mitigate\/"},"author":{"name":"Naren Madan","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/491011190655ca387dd093278b938927"},"headline":"Risk Management in Medical Devices: Evaluation, Mitigation &#038; 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