Software validation for medical devices is a requirement that applies to software that is used as a component of medical devices, or software that is by itself a medical device, and software used in the production of medical devices, or used in the implementation of the medical device manufacturer's quality system. In addition, any software used to automate any part of a medical device production process or any part of its quality system must also be validated for its intended use. Moreover, computer systems that create, modify, and maintain medical electronic records, or manage electronic signatures for medical records are also subject to validation requirements. Those systems and software applications must be validated in order to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered medical records.
"IEC 62304:2006 - Medical device software - Software life cycle processes" defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
The ultimate goal of Ginsbourg.com is to deliver a powerful and reliable service suite for building confidence in your medical software’s safety and effectiveness. The validation activities for each phase of the medical software development life-cycle are carefully planned, reviewed, and executed. Deliverable documents are printed in order to confirm the validation process and, in time, to present them to the regulatory authorities and appropriate notified bodies for accepting worldwide marketing approvals.
Software validation for medical devices includes consistent imperative tasks, e.g., performing a risk analysis, determining a level of concern, producing a comprehensive software documentation dossier (including a software requirements specification, a software design specification, a crosswise traceability analysis, etc.), execution and logging the validation and verification tests, and more. All the above activities and their branches are cordially provided as part of the full service.
With software validation service, you assure attaining CE marks, FDA approvals, and worldwide marketing certificates for your medical devices, innovations, and technology.