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    Medical Device Risk Management

    Medical Device Risk Management is a systematic approach of identifying, analyzing, evaluating, controlling, and monitoring all kinds of risk for a medical device from its design stage to end of life as per the standard ISO 14971.  All these activities and results are recorded in the Risk Management File.

    Medical Device Risk Analysis ISO 14971

    Medical Device Risk Management File (RMF)

    Medical Device Risk Management File  consists of a set of records and other documents, not necessarily contiguous, that are produced during the risk management process. The Risk Analysis is a process that could start from the design stage of a device to the entire life cycle. Hiring a third-party consulting company can help manufactures in multiple ways if planning for any regulatory submission s such as 510k or CE Marking as per MDR or IVDR.

    • Prepares the procedure for risk management as per the latest harmonized standard.
    • Reviews the existing documents related to risk management file belonging to the customer and can identify and fill the gaps with required information in particular for hazards, risks, and mitigation of risks.
    • Identification of new hazards
    • Documents the risk management activities that include planning, reports, assessments, the effectiveness of risk control measures, and post-market activities related to the risk management file.
    • For the residual risk, it performs risk-benefit analysis with the available information from the manufacturer and literature searches to prove that the medical benefit outweighs the residual risk.
    • Prepares conclusions and reports.
    • As consultants with up-to-date knowledge, we can help you manage the risk management file with the latest updates and moreover help you getting certification in less time period.

    Stages of Medical Device Risk Management

    1. Risk Management Plan

    Establish a risk management framework, assign responsible persons for each stage of risk management activity.

    2. Risk Analysis

    Identify characteristics according to the intended purpose, identify known or foreseeable hazards, and estimate risks for hazardous situations.

    3. Risk Evaluation

    Identify the severity and probability of risk.

    4. Risk Control

    Identify relevant risk control measures for each hazard and implement the risk control measures. Check new hazards or hazardous situations that may arise from the control measure implemented.

    Check if overall residual risks are acceptable. If residual risks are present, perform risk-benefit analysis.

    5. Risk Management Report

    Prepare Medical Device Risk Management Report and add relevant conclusions, production and post-production information review.

    Conduct of Medical Device Risk Analysis

    Risk analysis is a sequence of the process with the use of available information to identify hazards and estimate risk for each hazardous situation of a medical device in its normal use and faulty state. Risk Analysis shall be carried out in three stages.

    • Intended use and identification of characteristics related to the safety of the medical device- in this step identify the quantitative and qualitative characteristics of a medical device and its possible misuses.
    • Identification of Hazard- in this stage identify all possible hazards of a medical device in its normal use as well as in faulty condition.
    • Estimation of Risk for each Hazardous situations- in this stage, the Risk is estimated for each hazardous situation. Also, one can use any system to estimate the probability and severity of harm, this could be quantitatively or qualitatively.

     

    Medical Device Risk Management will require several representatives from various functions or disciplines with their specialist knowledge to form a risk management team. When required, the top management can hire external consultants or specialists to perform some risk management activities.

    Frequently Asked Questions

    What is Risk Management Review?

    A review of the medical device risk management process should be carried out. This review should ensure that the risk management plan has been appropriately implemented; the overall residual risk is acceptable; and appropriate methods are in place to obtain relevant production and post-production information. The results of this review should be recorded as the risk management report and included in the risk management file.

    What are the contents of Risk Management Report?

    The Risk Management Report shall have the review of the entire risk management process, and this review must have included:

     

    • the risk management plan whether it is implemented appropriately
    • Whether the overall residual risk is acceptable
    • Whether control measures are taken appropriately;
    • Whether appropriate methods are implemented to obtain relevant production and post-production information
    • Conclusions

    What are the possible risk arising from risk control measures?

    • The introduction of new hazards or hazardous situations;
    • whether the estimated risks for previously identified hazardous situations are affected by the introduction of the risk control measures.

    How to evaluate residual risk of a medical device?

    After the risk control measures are applied, any residual risk should be evaluated by the same method and with the same criteria for risk acceptability as the initial risks, as defined in the risk management plan. The results of this evaluation shall be recorded in the risk management file. The residual risk is either acceptable or unacceptable. If the residual risk is not judged acceptable after considering the risk control measures then Benefit – Risk analysis will be performed, if required.

     

    For residual risks that are judged acceptable, then it should decide which residual risks to disclose and what information is necessary to include in the accompanying documents in order to disclose those residual risks.