This work is Phase II of a research theme on the topic of human factors validation projects for medical devices and combination products. Initially, a review and analysis of the persisting concerns and also of the implications of failed FDA HF validation projects took place. One main problem delineated was that key stakeholders (namely procurers and providers of HF services) are lacking the necessary tools to adapt to current and future demands of a changing and evolving quality system regulation (QSR).

Under the QSR, manufacturers are responsible for the assessment and control of critical suppliers, such as HF service providers. However, there is a need for tools that enable integration and alignment so that stakeholders can develop the necessary capabilities. To increase the quality and success of HF validation projects and help HF service providers meet the QSR, an industry-focused project management (PM) maturity assessment tool was proposed. Phase I consisted of a survey that gathered interesting information to help understand practices and key success factors in FDA HF validation projects. This Phase II summarizes the method and process followed to develop the PM maturity assessment tool. An overview and description of the tool and its resulting components is also presented.