Design controls are a crucially important factor of development maturity in health tech development. They help ensure that manufacturers build medical devices that are of high quality, safe for both patients and the environment, meet the defined design inputs, and have all the process evidence for process improvement and for market access submissions.
Therefore, a thorough understanding of the purpose and stages of MedTech design controls is essential. Read this eBook to better understand what design controls are, and what benefits are associated with mature design controls! The eBook also provides a clear definition of key terms related to design control, differentiating between the Design History File, Device Master Record, and the Device History Record.
Download this eBook for actionable tips and best practices around implementing mature design controls in your health tech innovation projects!