This study seeks to investigate the impact of strengthened requirements for clinical
evaluation for medical device manufacturers in Europe due to the new Medical Device …

In today's rapidly evolving business environment, achieving operational excellence and
resilience has become paramount for organizations seeking sustainable success. The …

This study aims to develop and implement a Strategic Facility Planning process at a highly
regulated manufacturing site to optimise manufacturing space and capacity in a facility …

Purpose This study investigates the readiness for and understanding of Industry 4.0 in a
pharmaceutical manufacturer. Design/methodology/approach Utilising qualitative interviews …

To increase production efficiency at industrial enterprises, various digital technologies have
recently been used, which have various effects: reduction of time, money, material costs …

Purpose This paper aims to highlight how the six sigma methods helped the medical
equipment manufacturing company in finding and analysing the root causes that lead to the …

Purpose This research examines the implementation challenges and benefits of
transitioning to a paperless validation system as part of a Quality 4.0 initiative within a …

This paper's purpose is to outline the use of the Design for Green Lean Six Sigma (DFGLSS)
to evaluate bulk pharmaceutical product packaging and ascertain a path to its reduction and …

This research focuses on designing a clear methodology for problem-solving. It investigates
the application of a defined 'Lean'methodology for the proactive application of process …

Medical devices play an essential role in the delivery of healthcare but its use is not entirely
risk free. There are several instances where it causes mortality or morbidity among users. It …