Computational Modeling and Simulation (CM&S) plays a crucial role in advancing risk-informed decision-making, offering valuable support across various industries. While sectors like aerospace, automotive, and nuclear energy have embraced CM\&S for testing and regulation, its potential in the medical device realm remains underutilized. Bridging this gap requires leveraging credibility techniques from other fields and tailoring them to medical device evaluation. At the core of this endeavor is the development of an end-to-end computational model for a hypothetical medical device system, the Electronic Drug Delivery System (EDDS). This system involves the flow of a single fluid through the device, which undergoes heating by coils during the process. Consequently, a physics based computational model is required to simulate the fluid flow dynamics and the associated conjugate heat transfer phenomena within the device. This model is meticulously designed to meet the regulatory standards outlined by the U.S. Food and Drug Administration (FDA) and industry-recognized guidelines. Collaborating with the FDA and Sandia National Laboratories (SNL) enhances the study's depth, integrating Verification, Validation, and Uncertainty Quantification (VVUQ) techniques tailored to the FDA's regulatory framework. The research adopts a comprehensive approach, integrating VVUQ methodologies calibrated for risk-informed decision-making. Verification efforts, including numerical code verification quantification, along with validation using deterministic and probabilistic metrics, are employed to assess and ensure the accuracy of CM&S, enhancing its credibility. A comparative examination of commercial (ANSYS) and open-source (OpenFOAM) solvers reveals their respective strengths and similarities, providing valuable insights into widely used numerical solver software in medical device regulation. By publicly sharing the entire case study, including all relevant digital artifacts (data, code, and analysis), this will promote transparency and reproducibility in using CM&S for medical device regulation. These efforts aim to strengthen CM&S's role in risk-informed decision-making within medical device applications, advancing credible and reproducible evidence for informed regulatory assessments.