Strategies for Achieving Compliance: Laboratory Developed Software
Graduation Date
5-2017
Document Type
Master's Thesis
Degree Name
Master of Science
Department or Program
Clinical Laboratory Sciences
Department or Program Chair
Mary Sevigny, PhD
First Reader
Linda Liao
Second Reader
Howard Koo, MS, CLS, MT(ASCP)
Abstract
Laboratories are innovating the latest advancements in technology. One type of technology that has gained traction and recognition in the past decade is medical device software. However, many laboratories and lab professionals are unfamiliar with the regulatory requirements of software and how to implement them. While thorough testing and evaluation of custom laboratory developed software is being completed, the proper validation and verification processes are not always in place. IEC 62304 – Medical device software- software lifecycle processes was created to define the processes, activities and tasks necessary in creating a safe and effective medical device software. The same principles found in IEC 62304 can be applied when designing and creating laboratory developed software. Laboratories utilizing or designing laboratory developed software, who are considering on entering regulated environments (i.e. FDA) should consider IEC 62304 as a strategy for achieving compliance.
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