The customer is about to be re-certified in accordance with EN 13485 by the relevant body. Compliant processes and documentation need to be created. The customer develops, produces and sells class IIb devices. As such, the specifications of MDD, MEDDEV, EN ISO 14971, 60601-1, 60601-1-6, 60601-1-8, 60601-2-24, 62304, 62366, 62353 ff need to be observed.
Supplement
The project uses common MS Office programs for the Windows environment.
Subject description
The following standards are used for the consulting and later implementation: EN ISO 13485 for quality management, EN ISO 14791 for risk management, IEC 62304 for software development, 60601-1-6 and 62366 for serviceability and usability, 60601-1 for general requirements for the basic safety of electrical medical equipment and 60601-2-24 for the particular requirements for the safety of infusion pumps.