Management of requirements for a complex medical system, a repository-based example

 

The use of multiple databases for requirements driving the design of medical products impose a problem once the device is release to forward production and installed on the field. Multiple existing databases need synchronic updates and periodic maintenance due to the inherent disconnection from modifications performed on particular products, one at the time. Here, we describe a centralized, repository-based, database for medical device requirements that provide synchronic updates to all common products designed and manufactured in the company.