{"id":3450,"date":"2021-07-15T08:00:33","date_gmt":"2021-07-15T08:00:33","guid":{"rendered":"https:\/\/www.gilero.com\/uncategorized\/medical-device-risk-management-guide\/"},"modified":"2026-09-02T17:41:11","modified_gmt":"2026-09-02T17:41:11","slug":"medical-device-risk-management-guide","status":"publish","type":"blog","link":"https:\/\/www.sanner-group.com\/insights\/blog\/medical-device-risk-management-guide\/","title":{"rendered":"A Guide to Medical Device Risk Management & ISO 14971"},"content":{"rendered":"\n
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Medical device risk management is rightfully an essential component of medical product design and development. When it comes to putting a product on the market, risk analysis is required by law, and regulation checklists must be followed thoroughly. These regulations are carefully outlined in ISO 14971 to ensure all medical devices are safe before reaching users.<\/p>\n

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Why Is Risk Management So Important for Medical Devices?<\/h2>\n

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Medical devices are meant to help people and improve patient outcomes. If the product isn\u2019t safe and effective, however, it could end up causing serious harm to the user. That\u2019s why risk management is critical to every phase of a medical device project, no matter if you\u2019re designing a new revolutionary product or making small changes to an existing one. Rigorous commitment to medical device risk analysis not only helps ensure a safe and quality product, but is an important step on the path to gaining regulatory<\/a> approval.<\/p>\n

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Not being diligent about managing risk can also negatively impact budget and time to market. Without following a proper risk management process, you could end up with a project lacking certain mitigations that could affect your ability to get approval and require you to go back through the design and development<\/a> process.<\/p>\n

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Understanding the Role of ISO 14971<\/h2>\n

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ISO 14971 is the application of risk management to medical devices. It outlines the process device manufacturers should follow, from medical device risk analysis, evaluation, and mitigations to residual risk analysis and management. These standards are in place to ensure products are appropriately safe.<\/p>\n

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ISO 14971 outlines 10 basic steps to perform proper medical device risk management protocols.<\/p>\n

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1. Establish a risk management framework<\/strong>
\n-Define your process
\n-Delegate roles and responsibilities
\n-Document your plan
\n-Create a living risk management file<\/p>\n

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2. Specify intended use<\/strong>
\n-Define the scope of the device and document its intended use(s)<\/p>\n

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3. Identify any hazards<\/strong>
\n-Document potential sources of harm that could result from improper use or product malfunction<\/p>\n

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4. Define hazardous situations and foreseeable events<\/strong>
\n-Estimate the level of risk involved with each hazard<\/p>\n

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5. Estimate risk<\/strong>
\n-Assess the probability of harm occurring and its severity<\/p>\n

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6. Evaluate risks<\/strong>
\n-Determine if estimated risk levels are acceptable or if risk reduction is required<\/p>\n

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7. Perform risk control<\/strong>
\n-Reduce risks to acceptable levels<\/p>\n

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8. Evaluate overall risk acceptability<\/strong>
\n-Determine if you have reached an acceptable level of risk
\n-Identify if benefits outweigh potential risks<\/p>\n

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9. Review risk management<\/strong>
\n-Review your process
\n-Create a risk management report prior to production<\/p>\n

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10. Collect production and post-production information<\/strong>
\n-Perform and analyze internal audits, CAPAs, complaints, customer feedback, and non-conforming materials to improve your risk management process<\/p>\n

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Read official guidance on the application of ISO 14971.<\/em><\/a><\/p>\n

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Our Medical Device Risk Management Process<\/h2>\n

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Risk management is inherent to Sanner\u2019s process for medical device development. We operate multiple global sites with equivalent Quality Management Systems (QMS), meaning we have numerous procedures, work instructions, and forms in place to help manage risk at every level of our organization. A few areas of emphasis within our process include:<\/p>\n

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