Malsen Medical has added collaborative requirement management to our toolbox. Managing requirements, specifications, associated test cases and results is at the very core of controlled development. The image below shows an illustrative example of requirement traceability for a typical device. Each requirement needs to be uniquely identified and a history of changes needs to be maintained. The traceability of fulfilment of each requirement through detailed specification and testing needs to be demonstrated.

Some try to use Microsoft Excel for this kind of work, but soon find the limitations of such an approach. It is simply not possible to maintain the required control of requirements using tools such as Microsoft Excel. On the other extreme end are extremely heavy tools, such as DOORS from IBM. Then there are a range of online tools which more or less have the capability required. Online tools for requirement management can be problematic due to the very confidential nature of this data and often come with a near impossibility to export the data.

Here at Malsen Medical, we believe that Reqview is the best tool for requirement management for typical development projects.  It allows for local, yet synchronized, storage of requirements and enables very controlled export of requirements for documentation purposes.

We believe in the power of collaboration and when you work with us you gain access to requirement collaboration for teams. The figure below illustrates how this works. When your project is set up with us, the Malsen Medical collaboration server ensures that everyone in the team works with the same data through secure synchronization.  Change control for each requirement and the database as a whole is maintained for each and every change made.

The Malsen Medical team will support you to develop good, compliant requirements and ensure efficient implementation.

For more information see https://reqview.malsenmedical.com