Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA and recognized by the FDA as a consensus standard. Within ISO 13485:2016 “Medical devices—Quality management systems—Requirements for regulatory purposes”, the term “risk” is referenced over 15 times, placing more an emphasis on risk in comparison to the previous revision where it was only mentioned twice, therefore ensuring the manufacturer establishes a risk-based approach to product lifecycle. The expectation isn’t that risk can be completely avoided; however, it can be minimized, if the company is aware of the associated risks. ISO 14971 encompasses more than just the risk to the patient, it also considers the risks to others i.e. equipment, environment and operators. Risk should be managed throughout the lifecycle of the device from initial concept to the disposal of the device. ISO 14971 is a risk management tool which ensures there is a systematic approach is undertaken, when ensuring risk management is applied throughout the QMS (Quality management system). It ensures that management and appropriately trained personnel are involved in making of product related decisions and reviewing effectiveness. Risk Management Process Flow 1. Risk management framework and planning. The manufacturer should define the risk management process, defining the roles and responsibilities and document a risk management plan. The medical device and medical device family groups will be within … Continue reading The Importance of Risk Management