The basic approach in CE marking allows manufacturers a great deal of freedom, up to and including self-declaration of conformity. Conversely, manufacturers bear a high degree of direct responsibility, which they must fulfill for regulatory and liability reasons. In the CE certification of medical devices, systems and processes for the area of risk management are specified by the international standard EN ISO 14971. The content of this standard refers to the various procedures for managing risks posed by medical devices to patients, users, other persons as well as the environment and equipment. With our expertise, we continuously support you in all phases of compliance with the EN ISO 14971 standard.
Our service starts with the planning and development of a risk management system tailored to your needs, and extends through implementation to maintenance, and also includes the establishment of an appropriate documentation system.