ISO 14971 calls for a risk management process for medical device manufacturers and their accessories that identifies the medical device hazards, assesses risks, describes risk mitigation measures and monitors the effectiveness of these measures. The requirements of the standard apply during all phases of the product life cycle of a medical device, also after the product is already on the market.
Risk management is an essential part of development, but also during the production and post-production phase of medical devices. Benefit from the many years of experience of our experts and risk managers.
We support you in the development and implementation of a risk management process according to ISO 14971 by creating process descriptions, work instructions and form sheets. During the implementation, our specialists work with you to determine adequate acceptance criteria for your products and guide you through the identification of hazards and the risk assessment and support you in risk control and the risk-benefit analysis. We also consider international technical reports and guidelines, such as ISO/TR 24971, IEC/TR 80002-1 and ISO/IEC Guide 63.