Breaking Down Risk for Medical Device Hazard Analyses
ABSTRACT
In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance. A clear, intentional structure supports traceability, aligns with ISO 14971:2019, and enables effective risk control. This article explores three common structures for hazard analysis and highlights a flexible, practical option that aligns well with real-world data and regulatory expectations.
Taylor Dieringer
Risk Management Quality Engineer, MEDIcept Inc.
Taylor Dieringer has practiced experience in the medical device and pharmaceutical industry. As a Risk Management Quality Engineer at MEDIcept, Taylor is focused on providing guidance respective to ISO 14971:2019 and developing quality systems to embed risk-based decisions into the design control, process validation, and post-market surveillance procedures. Taylor holds a Bachelor of Science in Biomedical Engineering from the Milwaukee School of Engineering (MSOE) and is currently pursuing a certificate in Medical Device Quality Design from University of Californica (UC) Santa Cruz.
