Orcanos 5th Annual Medical Devices Software Development Summit
QPack is a software system designed to support the software lifecycle management compliance in medical device products, according to the FDA General Principles of Software Validation, IEC 62304, and ISO 14971.
QPack provides a set of integrated tools for software verification and validation, risk management, requirements traceability test management and defect tracking with the ability to automatically generate validation documents (MRD, PRD, SRS, SDD, STD, STR) .