Risk management is a key component in demonstrating regulatory compliance for medical devices. The requirements for medical devices, including the Medical Device Directive, the Active Implantable Medical Device Directive and the In-Vitro Diagnostics Directive, detail the requirement for risk management.
The Medical Device Directives require implementation of a Quality Management System, for which the harmonized standard is ISO 13485. This Standard also details requirements for demonstration of risk management. ISO 14971 is the harmonized standard for risk management; meeting standard demonstrates compliance to the requirements.