Strategies for Achieving Compliance: Laboratory Developed Software

<p>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.</p>

Name thesis:degree_name

Master of Science

Level thesis:degree_level

Master's Thesis

Discipline thesis:degree_discipline

Clinical Laboratory Sciences

Year dc:date.available

2017

Author dc:creator

• Aquino, Christine

Contributors dc:contributor

• Linda Liao
• Howard Koo, MS, CLS, MT(ASCP)

• IEC 62304
• Compliance
• Laboratory Developed Software
• Medical Device Software
• Software Lifecycle
• Biotechnology
• Health Information Technology
• Laboratory and Basic Science Research
• Molecular Genetics

Repository record dc:identifier

https://scholar.dominican.edu/masters-theses/262

OAI identifier oai:identifier

oai:scholar.dominican.edu:masters-theses-1278