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.

ISO 14971:2019 Risk Management for Medical Devices

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In the medical device industry, risk management is a vital part of all your company’s processes. Hear from Dr Peter Bowness, Medicinal and Biologics Technical Team Manager, about the updated ISO 14971 and what has changed from the previous version of the standard.

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.