ISO 14971 Risk Management

Optimize your risk management system

ISO 14971 risk management medical devicesIn the medical device industry, risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

Regulatory requirements for risk management

Risk management is a key component in demonstrating regulatory compliance for medical devices. The requirements for medical devices, including the Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In-Vitro Diagnostics Directive (98/79/EC), detail the requirement for risk management. In addition, the Medical Device Directives require manufactures to implement a Quality Management System (QMS), for which the harmonized standard is EN ISO 13485:2012. This QMS Standard also details requirements for demonstration of risk management. EN ISO 14971:2012 is the harmonized standard for risk management; meeting the requirements of the Standard can help you to demonstrate compliance to the requirements.