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ISO 14971 Risk Management for Medical Devices
Achieving compliance with ISO 14971:2019 is a critical requirement for medical device manufacturers aiming for CE Marking under the EU MDR 2017/745. This international standard provides a structured framework for identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their lifecycle.
At RegHelps, we specialise in risk management consulting tailored to medical device companies of all sizes and risk classes. Our experts help you develop fully compliant Risk Management Files (RMFs) that integrate seamlessly with your technical documentation, design controls, and clinical evaluation.
Whether you’re designing a Class I reusable surgical tool or a high-risk Class III implantable device, our consulting ensures your risk analysis, risk evaluation, and residual risk justification stand up to scrutiny by Notified Bodies.
Key Highlights:
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End-to-end support in ISO 14971:2019 compliance
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Customized risk analysis (FMEA, FTA, Hazard Matrix, etc.)
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Alignment with EU MDR expectations and GSPR requirements
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Risk Management File (RMF) preparation and review
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Gap assessment of your existing documentation
Why ISO 14971 Risk Management Matters for Device Regulatory Submissions
Whether you’re submitting a medical device for EU CE Marking, FDA 510(k), Health Canada approval, or other global regulatory pathways, ISO 14971-compliant risk management is a non-negotiable requirement. Regulatory bodies worldwide expect manufacturers to systematically identify, evaluate, mitigate, and monitor potential risks associated with their devices from design stage through post-market use.
ISO 14971 provides the framework and structure for achieving this. It ensures that your risk management process is documented, traceable, and defensible during regulatory review.
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ISO 14971 is accepted by regulators worldwide and cited in MDR (EU), FDA guidance, and IMDRF standards.
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Risk management evidence must be aligned with design controls, clinical evaluation, labelling, and usability reports.
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Clear traceability from hazards to risk controls and benefit-risk justification strengthens your overall submission.
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A well-prepared Risk Management File (RMF) can reduce queries, deficiencies, and review cycles.
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Regulators increasingly look for how risk is monitored post-market through PMS and CAPA systems — a key expectation under MDR and FDA QSR.
ISO 14971 Risk Analysis
Risk analysis is a series of steps that use available data to identify safety-related features, identify hazards, and estimate each hazard of medical devices in both their normal and defective states.
For MDR, IVDR, FDA, or any other regulation, the manufacturer must establish the device’s safety. As a result, risk analysis based on ISO 14971 is required and becomes a requirement. This standard’s requirements apply to the whole life cycle of a medical device.
Risk Analysis shall be carried out in three stages.
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Intended use and identification of characteristics related to the safety of the medical device- in this step, identify the quantitative and qualitative attributes of a medical device and its possible misuses.
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Identification of Hazard- in this stage, identify all possible hazards of a medical device in its regular use and faulty condition.
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Estimation of Risk for each Hazardous Situation- the Risk is estimated for each hazardous situation in this stage. Also, one can use any system to estimate the probability and severity of harm; this could be quantitatively or qualitatively.
The manufacturer must show conformance with the general safety and performance requirements, as well as other requirements such as quality and medical device risk management, according to MDR and IVDR Essential Requirements. EN ISO 14971:2020 is currently harmonised with MDR and IVDR.
Risk Benefit Analysis
Assume that the residual risks are unacceptable even after medical device risk management procedures have been adopted. In that instance, we perform a risk-benefit analysis to show that the device’s benefit surpasses the hazard. To do so, all remaining risks and advantages associated with the device’s intended purpose are analyzed subjectively and statistically to arrive at a risk-benefit ratio assessment. The benefit-risk analysis analyses if the benefit is greater than the hazard.
The risk-benefit analysis must be conducted to demonstrate that the device’s benefit outweighs the risk associated with it to show the device’s safety while performing its intended function and overall risk acceptance.
The worldwide standard for doing risk-benefit analyses for medical devices is ISO 14971. Suppose the remaining medical device hazards are unacceptable even after implementing risk management measures. In that case, we do a risk-benefit analysis to demonstrate that the device’s benefit outweighs the risk. To do so, all remaining hazards and advantages associated with the device’s intended purpose are examined subjectively and statistically to arrive at a risk-benefit ratio value estimate. The benefit-risk analysis analyses if the benefit is greater than the risk. The benefit-risk balance must be based on appropriate clinical evidence and be reviewed and reassessed regularly.
Risk Management and Role of Consultants
Assume that the residual risks are unacceptable even after medical device risk management procedures have been adopted. In that instance, we perform a risk-benefit analysis to show that the device’s benefit surpasses the hazard. To do so, all remaining risks and advantages associated with the device’s intended purpose are analyzed subjectively and statistically to arrive at a risk-benefit ratio assessment. The benefit-risk analysis analyses if the benefit is greater than the hazard.
The risk-benefit analysis must be conducted to demonstrate that the device’s benefit outweighs the risk associated with it to show the device’s safety while performing its intended function and overall risk acceptance.
The worldwide standard for doing risk-benefit analyses for medical devices is ISO 14971. Suppose the remaining medical device hazards are unacceptable even after implementing risk management measures. In that case, we do a risk-benefit analysis to demonstrate that the device’s benefit outweighs the risk. To do so, all remaining hazards and advantages associated with the device’s intended purpose are examined subjectively and statistically to arrive at a risk-benefit ratio value estimate. The benefit-risk analysis analyses if the benefit is greater than the risk. The benefit-risk balance must be based on appropriate clinical evidence and be reviewed and reassessed regularly.
service related FAQ’s
All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.
Some key documents include the Technical Documentation (Annex II & III), Clinical Evaluation Report (CER), Risk Management File, PMS/PMCF Plans, and labeling/instructions for use (IFU) compliant with GSPR
All MDD-certified devices must transition to MDR compliance by the applicable deadline. Significant changes to the product or intended use may require a full MDR re-certification.
