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Keywords: Medical device
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Journal Articles
Electronic validation systems as an aid to quality and regulatory compliance in the medical device and pharmaceutical industries
Available to Purchase
Journal:
The TQM Journal
The TQM Journal 1–16.
Published: 22 September 2025
...Olivia McDermott; Neasa Conroy; Aidan P. Toner; José Carlos Sá; M. Thenarasu; M.S. Narassima Purpose This research examines the current status of the implementation of digitalised validation systems within the Irish Medical Device and Pharmaceutical industries, as well as the benefits...
Journal Articles
Journal:
The TQM Journal
The TQM Journal (2023) 35 (9): 42–58.
Published: 28 February 2023
...Anna Trubetskaya; Olivia McDermott; Anthony Ryan Purpose This paper outlines how Design for Lean Six Sigma methods aided a medical device manufacturing company in developing a new strategic space management and approval process for its manufacturing site. Design/methodology/approach...
Journal Articles
Critical failure factors for continuous improvement methodologies in the Irish MedTech industry
Open Access
Journal:
The TQM Journal
The TQM Journal (2022) 34 (7): 18–38.
Published: 10 March 2022
... of CI methodologies in the Irish medical device (MD) industry. Design/methodology/approach A quantitative survey was utilised in this study. The main participants were made up of senior quality professionals working in operational excellence, quality consultants, quality directors, quality engineers...
Journal Articles
Building a sustainable high-performance customer experience and product performance (CxPP): the JJV experience
Available to Purchase
Journal:
The TQM Journal
The TQM Journal (2021) 33 (8): 1806–1824.
Published: 13 April 2021
...; types of projects, type of customer need and feedback should be specific to each environment. Originality/value This paper fulfills an identified need to study the relationship between product quality, customer satisfaction and sales. Customer experience Product improvement Medical device...
Journal Articles
Establishing a small company's medical device quality system
Available to Purchase
Journal:
The TQM Journal
The TQM Journal (2012) 24 (4): 363–373.
Published: 08 June 2012
...Madhav Sinha; January Luczak Purpose The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way. Design/methodology/approach...
