Risk management for the patients‘ safety
The principle approach within the process of CE-marking grants manufacturers a lot of freedom, up to the self-certification. On the other hand manufacturers bear a high level of responsibility, which they have to fulfill for regulatory and liability reasons. Within CE-marking of medical devices, systems and processes for risk management are outlined in the international standard EN ISO 14971. The standard refers to the various procedures for the management of risks that medical devices include for users and patients, as well as other persons, environment and equipment.
Our extensive expertise in the field of risk management enables us to reliably support you during all phases of the fulfillment of EN ISO 14971 requirements. Our service starts with planning and developing a customized risk management system that suits the needs of your company; extends over implementation and maintenance and also includes the development of an appropriate documentation system.