document - Ready for certification
The documentation lists all measures conducted in the development of a usable and safe product. This complete, systematic, and extensive proof is optimized to meet the requirements of the notified bodies.
During the entire product development process, the procedure is documented according to the requirements of DIN EN 60601-1-6, in future EN 62366, and ISO1497:2007.
DIN EN 60601-1-6 - Usability File and Risk Management File
The usability file defines all important steps and usability engineering results. The document includes reports on the different phases of the process as well as a summary of the relevant data. Simultaneously, on the basis of the risk analysis the risk management file ist being generated. Finally, the documents of the clinical evaluation (Design Evaluation Report) of the commissioned Clinical Research Organization are incorporated in the overall documentation.
As a manufacturer of an innovative medical product, you will receive an overall document for project completionin a consistent layout including all necessary accompanying documents. For the certification, you will then submit this overall document directly with your product to a notified body.