QPack is an end-to-end solution for Application Lifecycle Management, containing all development lifecycle modules, such as market requirements, system specs, development, testing, and delivery. QPack ALM supports the marketing team, system architects, developers and testers by providing each team with professional tools suited to its specific needs and methodologies. QPack is cost effective, easy to use and requires very little maintenance. By using the requirements definition tool and release manager, QPack ALM solution makes it possible to determine the precise feasibility of new functionality and see the impact of changes, all while taking into account the time constraints of release to market. QPack application lifecycle management solution for medical device provides a single repository of data management for medical device development, providing professional ALM tools for all parties involved with the medical device software development, including market requirements (MRS), product requirements (PRS), risk management tool according to the FMEA standard and validation and verification. QPack for medical device software development supports compliance with the FDA regulations, providing the customer with an end-to-end solution for the medical device development process. QPack medical device software development provides the followings modules: Market requirements management (MRS) Product requirements management Electronic records and signatures Document control Audit trail Full traceability Validation.