Medical device risk assessment involves the complex task of making sure new medical devices are safe for human use. This, of course, implies that medical devices are safe as well as effective.
Medical devices developed for human application are used for diagnostic or treatment purposes. They may either be an instrument, an apparatus or a material. Additionally, devices can be used for daily patient care as well as for medical scientific purposes.
Medical device risk assessment involves the identification, understanding, controlling, and preventing failures that can result in hazards when people use medical devices. Risk Analysis plays a key role in the development of medical devices design.
Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which could be encountered in connection with the use of taking a drug, or using a medical device.
Manufacturers are expected to identify possible hazards associated with the design in both normal and fault conditions. If any risk is judged unacceptable, it needs to be reduced to acceptable levels by appropriate means.
ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire lifecycle of a device. To ensure organizations bring a compliant product to market efficiently and safely, organizations need to successfully implement a risk management system.
ISO 14971 specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
The purpose of ISO 14971 is to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Want to learn more? Tonex offers Medical Device Risk Assessment Training, a 2-day course that covers the importance of Risk Analysis, Risk Management Process, Application of Risk Management tools, and the benefit of the Risk Management Analysis to medical devices.
Participants will learn how to minimize use-related hazards, assure that intended users are able to use medical devices safely and effectively throughout the product life cycle, and to facilitate review of new device submissions and design control documentation.
For more information, questions, comments, contact us.