1 Summary
The report published on this website is a draft and subject to frequent updates. Please be aware that the content may change over time as revisions are made. Thank you for your understanding.
If you have questions, comments, or feedback, please contact Esteban Solorzano.
The field of medical device development is rapidly evolving, driven by technological advancements and the increasing complexity of healthcare systems. Ensuring the safety, efficacy, and compliance of these devices is paramount for protecting patient health and well-being. In response to this need, this project proposes the creation of a comprehensive knowledge repository focusing on the systems engineering aspects of medical device development. The objectives of this endeavor include designing a cohesive resource that compiles knowledge and best practices, educating professionals and students in systems engineering about the unique challenges of medical devices, offering practical guidance throughout the device lifecycle, and deepening understanding of regulatory requirements. The proposed methodology entailed developing the book systematically, incorporating industry standards and literature reviews, gathering insights through interviews and surveys, structuring content with clarity and coherence, and validating accuracy through peer review. Leveraging tools like Git and GitHub, this project aims to facilitate collaboration and ensure the relevance of its content. This report encapsulates the systematic approach and comprehensive scope of the project, promising to deliver a valuable resource for those involved in medical device development and systems engineering.