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2 Case Study Efficiency Helps Vascutek Maintain Compliance Whilst Saving Money Efficiency Helps Vascutek Maintain Compliance Whilst Saving Money Vascutek, a Terumo Company, is a world leader in the design and manufacture of products that address the needs of vascular and cardiovascular clinicians throughout the world. Based at a custom-built factory in Inchinnan, Scotland, near Glasgow, Vascutek currently employs 600 associates. The company also has a valve manufacturing facility in Leeds with around 80 associates. For over thirty years, Vascutek has applied advanced and innovative technologies to develop a wide portfolio of products which include a stent graft system to treat abdominal aortic aneurysms (this is a bulging of the abdominal wall), an extensive range of knitted and woven grafts for peripheral, abdominal and cardiothoracic surgery, and heart valves. Vascutek distributes its products to over 100 markets worldwide. Being a global medical device company, Vascutek is required to meet the requirements of major regulatory bodies, for example, the Food and Drug Administration (FDA) in the USA. The company is also subject to compliance with ISO 13485 and ISO 9001 standards. Challenges Like many medical device companies doing business nowadays in a regulatory focused environment, Vascutek has thousands of controlled documents, standard operating procedures (SOPs), drawings, non-conformance reports (NCRs), complaints, R&D papers, MIS documents, management reviews, plus many other types of important documentation Being a fast-growing medical device company, Vascutek found itself facing a major challenge several years ago. Managing all the documents and training necessary for regulatory compliance with homegrown, paper-based systems was not cost effective because such systems are inefficient, slow, and prone to errors. Up until a few years ago all of Vascutek's processes were paper based. Drawings and procedures could not be circulated together when changes were made and, because the system was not electronic, drawings could not be viewed on the system by company users. Redlines on documents or change notes couldn't be viewed either.

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