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.