We provide several verification reviews, code review and test to DHF documentation regulatory review. This ensures that the controls are in place and the software is of the utmost quality.
Our team of expert software engineers, work WITH you to refine requirements, recommend solutions and create a sustainable software architecture to meet the needs of your project.
We bring our breadth of software experience, knowledge, pre-validated libraries and tools to ensure that your project will be developed efficiently and to the highest standards.
Using our ready-made templates and checklists, we provide the complete Design History File (DHF) for the software, compliant to FDA 510(k) and IEC 62304 standards.