Risk Analysis for Medical Devices based on the requirements of ISO 14971
Risk is a measurable factor. It is defined by safety specialists as a function of the severity of the hazard and the probability that the hazard will occur. Safety, however, cannot be measured precisely. It requires a judgement by designers and production professionals acting together with management, taking account of what is technically and economically feasible. The assessment of safety involves balancing the risks that cannot be eliminated from the product against the benefit and utility of the product. These two factors (probability and severity) form the basis for a product safety profile, which provides management with information to decide whether to bring a device to market.
Risk analysis is required by FDA’s Quality System Regulation (QSR) and the Annex I Essential Requirements of the European Union’s three Medical Devices Directives (Active Implantable, Medical Devices and In Vitro Diagnostics). The EU requires a risk analysis for all medical device technical files, including those already on the market. Also, risk analysis does not just occur during design control, it should be applied throughout the processes for product realisation.
- Expectations of the FDA and the EU in applying risk analysis to medical devices.
- Risk management requirements and the purpose of ISO 14971.
- The application of ISO 14971 to medical devices.
- The principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks.
- Sources of information and further development
- R&D Managers / Engineers
- RA / QA Managers / Engineers
- Management Representatives
- Members of multi-discipline Design Teams
- Members of Design Review Teams
- Sales and Marketing Management
- Product, Project, and Program Managers
- Internal Auditors
- Apply the process to conduct risk analysis to identify hazards, their severity and the probability they might occur.
- Apply risk evaluation and risk control principles to their devices including regulatory requirements, technical costs, accident costs, liability costs and insurance costs, which affect decision making on the acceptability of risks in bringing a device to market.