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dc.contributor.authorFoley, Aisling.
dc.contributor.otherMcDermott, Olivia
dc.date.accessioned2018-01-30T15:01:57Z
dc.date.available2018-01-30T15:01:57Z
dc.date.issued2017
dc.identifier.citationFoley, Aisling (2017) Lean thinking for regulatory processes. M. Sc., Institute of Technology, Sligo, NUI Galway.en_US
dc.identifier.otherMScen_US
dc.identifier.urihttps://research.thea.ie/handle/20.500.12065/2237
dc.description.abstractMedical Device Manufacturers are faced with the challenge of changing regulations. Although there are global harmonization efforts, regulations are become more complex and challenging to manage. In the next few years’ manufacturers must manage significant transformations to their organization due to the changes in regulations e.g. EU MDR and MDSAP. Not all manufacturers are able to allocate sufficient resources to handle the changes. Instead of adding more resources, manufacturers should look at smarter ways manage their regulatory processes. While some companies are taking innovative steps to changing the way they manage regulatory compliance, it is not something that is widely adopted in industry. There is hesitation to change the way we work for fear of cost implications, project delay and even product withdrawals. In Regulatory Affairs, the instinct may be to provide too much information, to cover all potential scenarios. However, provided the risk to the patient is always at the forefront, over-information may be to our detriment. Over-information is a form of waste, as it hides problems and inefficiencies. There are many forms of waste in Regulatory processes e.g. over-information, rework, waiting. If manufacturers look at smarter ways to manage the processes, they can reduce the waste, reduce the process time, improve compliance and improve quality of data. Lean tools are an excellent way to manage these process transformations. Using lean tools like Kaizen, Just-in-Time, Kanban, Standardisation and 5S manufacturer can transform these processes. Although there are challenges with using lean tools, the challenges can be overcome through education and training of employees; commitment from management to drive the lean culture; and through the correct use of lean tools. The medical devices industry is an innovative and competitive industry. For manufacturers to stay competitive they must be able to bring their products to market in quick and cost effective way. The manufacturer that uses lean tools on their regulatory processes, will be able to get their products to market quicker than those who don’t use lean. Not only does the use of lean tools benefit the manufacturer, it ultimately benefits the patient, as new products will be brought to the market quicker than before.
dc.formatPdfen_US
dc.language.isoenen_US
dc.subjectMedical instruments and apparatus industryen_US
dc.subjectRecording and registrationen_US
dc.subjectTechnology, Medicalen_US
dc.titleLean thinking for regulatory processes /en_US
dc.typeThesisen_US
dc.publisher.institutionInstitute of Technology, Sligoen_US
dc.rights.accessCreative Commons Attribution-NonCommercial-NoDerivsen_US
dc.rights.embargodate3rd November 2021.en_US
dc.subject.departmentDept of Life Sciences, ITSen_US


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