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 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
2. Risk Analysis
3. Risk Evaluation
4. Risk Control
Check if overall residual risks are acceptable. If residual risks are present, perform risk-benefit analysis.
5. Risk Management Report
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?
What are the contents of Risk Management Report?
- 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
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?
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.