Home // International Journal On Advances in Life Sciences, volume 9, numbers 1 and 2, 2017 // View article

Becoming a Medical Device Software Supplier and Complying with Data Security Regulations

Authors:
Fergal McCaffery
Ronald Jabangwe
Kitija Trektere
Garret Coady

Keywords: MDevSPICE Framework; Software Development Process; Medical Device Software; Software Security; HIPAA; Agile Software Development.

Abstract:
Today many software development companies are restructuring their business model to enter the medical device domain. The reason for this change is that significant opportunities exist within the healthcare industry and particularly in relation to the usage of software within this domain. However, in order to become either a medical device software supplier or manufacturer there are challenges to overcome, and data protection regulations to abide by. This paper describes a case study of an Irish software development company that in 2014 decided to change their business model to enable them to become a medical device software supplier, and engaging with clients in the United States of America. The paper provides an account of their journey from being an automotive software supplier to securing software development contracts from leading medical device manufacturers. This involved them having to re-design and re-structure their software development approach to meet both the demands of medical device standards, data security regulations and medical device multinational third party software selection criteria.

Pages: 11 to 20

Copyright: Copyright (c) to authors, 2017. Used with permission.

Publication date: June 30, 2017

Published in: journal

ISSN: 1942-2660