Insulin infusion pumps are safety-critical systems that require the approval of government regulatory agencies, such as the United States Food and Drug Administration, before commercialization to prevent hazard situations. This master's dissertation aims to assist manufacturers evaluate quality attributes, e.g., safety, of insulin infusion pump systems for certification purposes. A coloured Petri nets (CPN) model-based approach of insulin infusion pump systems is proposed based on the improvement of an existing CPN reference model by integrating it with a Web Java Application. An empirical study is conducted to evaluate the proposed approach considering the specifications of the ACCU-CHECK Spirit infusion pump system. The approach is made freely available for manufacturers assess quality of insulin infusion pump systems under development, or to identify sources of recalls in previously certified systems. The usage of the model-based approach can decrease costs and development time of insulin infusion pump systems, in addition to increase confidence on quality attributes such as safety and effectiveness.