Design Reliability and Risk Management in Medical Devices: A DRM-Based Approach
Keywords:
Design Reliability, Risk Management, Medical Devices, DRM-Based Approach, Patient Safety, Regulatory Compliance, Author Name, Scopus, Springer, Journal Name, Wissira, Journal Short Form, Wissira Press, Wissira Research Lab, Research Gate, SSRN, ISSN, Academia, UGC Care, PubMed, WOSAbstract
This manuscript presents an integrated approach to design reliability and risk management (DRM) specifically applied to medical devices. It emphasizes a systematic framework for identifying, analyzing, and mitigating potential design and operational risks during the development life cycle. By combining established reliability engineering methods with modern risk management strategies, the DRM-based approach addresses regulatory demands, enhances patient safety, and ensures robust device performance. The paper discusses a detailed literature review of current methodologies, presents a statistical analysis based on reliability test data, outlines the methodology behind the DRM process, and reports on results from case studies and simulations. Overall, the findings suggest that incorporating a DRM-based framework in the design process can lead to significant improvements in device safety, reliability, and market approval success.
