The reason: The respective contractual partner provides additional requirements for the product, which may not have the raw material. Often, these compatibility requirements with a defined hardware partner, the software should run on the refer. Even though it’s nearly identical products, the requirement management of a development project on the other is often matched. Rather, both are detached from each other. Changes in requirements in a project are not necessarily communicated to other projects. Important knowledge and valuable insights for the development of the product are not considered if necessary, although this knowledge and these findings in the present company are. Considering the above situation of not Verlinktseins of related”development projects based on product complaints are taken by customers and partners only for the respective products to which the complaint relates. Related”products, which have the same or similar requirements as the faulty product, disregarded this.
That is, the claim of a product failure will not flow in the request and the related risk management “medicine product. How can synergies be produced so? How can a communication between the project teams in relation to requirements and risk management related’ products take place? “The solution could be a relational database application, that driven requirement engineering allows a risk, where each request according to kinship” refer to each other via a matrix structure. In addition to the compliance with the statutory requirements in relation to risk management in accordance with the EC directive for Medical devices 93/42/EEC and EN ISO 14971, the requirements of standards for quality management for the manufacturing of medical devices in accordance with EN ISO 13485 and the specific standard for the development of medical software in accordance with the EN ISO be 62304 medical device software, software life cycle processes”as requirements in relation to the validation of software applications (keyword: usability or usability) taken into account. Should you have further questions about risk management and requirements engineering, we would be very pleased your call or email. Munich, Thomas Baier senior QM consultant who qcompetence the qcompetence GmbH is a consulting firm for risk and quality management, as well as for the approval of medical devices.