<p>The integration of computational modeling and digital twin (DT) technologies is revolutionizing the development and lifecycle management of medical devices. This manuscript explores the pivotal role of these advanced tools in enhancing device design, safety, efficacy, and regulatory compliance. Computational modeling enables in silico testing, reducing reliance on traditional experimental procedures, while digital twins offer real-time, patient-specific simulations that support personalized healthcare solutions. The application of these technologies’ spans from early-stage product design and virtual prototyping to performance prediction, failure analysis, and post-market surveillance. Furthermore, their incorporation facilitates iterative development, accelerates regulatory approval pathways, and enhances decision-making throughout the product lifecycle. Challenges such as data integration, model validation, regulatory standardization, and cybersecurity are also discussed. The paper emphasizes the transformative potential of computational modeling and digital twins in fostering innovation, improving patient outcomes, and advancing precision medicine in the medical device sector.</p> Graphical Abstract <p></p>