Integrated process approach for hardware/software development, risk management, usability and corresponding documentation
As the complexity of medical devices increases, the need for consistent and methodically prepared documentation becomes greater as well. Especially the FDA but increasingly also the notified bodies in Europe are tending to reject incomplete or intransparent approval documents more frequently. Our approach is to merge the device architecture and lifecycle activities more closely with documentation in the course of development. We realize this through a consistent layer model that utilizes the logical levels of the V-model, and combine this with a modularization concept that calls for a consistent set of documents for each subsystem of the medical device. The documents belonging to a subsystem are clearly presented in a design control chart, making it much easier for you to conduct audits successfully.