Title

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, Ph.D.

First Reader

Linda Liao

Second Reader

Howard Koo, M.S., 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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