ISO 14971 Risk Management Consulting for Medical Device Companies

Risk management is an important part of the medical device product development lifecycle. It helps medical device manufacturers to ensure that the final product is reliable, works as expected, and causes no harm. The main purpose of the risk management process is to reduce or mitigate the chances of failure in the product.

What ISO 14971 is important?

ISO 14971 helps your company establish, document, and maintain a systematic process to manage the risks associated with the use of a medical device. This includes ongoing monitoring of field experience, thereby embracing the concepts of continuous improvement and state-of-the-art device performance. To maximize the effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485.

Steps Involved in Risk Management for Medical Devices

·         Risk Management Framework & Planning

·         Risk Analysis

·         Risk Evaluation

·         Risk Control

·         Reports and Documents

·         Production & Post-Production Information

Why should we perform Risk Management?

·         To identify hazards

·         To estimate & evaluate the risk

·         Risk analysis is required by law

·         Identification of device design problems prior to distribution eliminates extra costing associated with the medical device

·         To ensure the safety of the medical device

IZiel Healthcare team uses the structural approach defined by ISO 14971 to construct the risk management file. The risk management file starts with drafting the risk management plan; it consists of the methodology of a risk management process and risk policy. Afterwards, hazards, hazardous situations, and harm are determined using tools like FMEA (pFMEA and dFMEA) and hazard analysis. The identified risks are then controlled or mitigated by applying risk control and the evaluation of residual risk then follows it. If the residual risk is not acceptable, then a risk versus benefit analysis is carried out.

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