CIMdata PLM Industry Summary Online Archive
7 January 2013
Implementation Investments
Medical Technology Manufacturer OLYMPUS Concludes Framework Agreement with CONTACT
CONTACT Software and Olympus Surgical Technologies Europe have concluded a framework agreement. It defines the basic cornerstones for future collaboration between the two companies and will apply to all the medical technology manufacturer's sites in Germany, the Czech Republic and Wales. The key agreements relate to the extension of the CIM DATABASE platform for product lifecycle management (PLM). Primary focus is placed on enterprise-wide document and project management designed to take account of global regulatory requirements – such as those issued by the American Food and Drug Administration (FDA) or set out in ISO 13485 – that are implemented in the form of device master records (DMR) and design history files (DHF). One further element in the agreement is CONTACT's qualification as a supplier that meets the requirements of an FDA-certified company.
The FDA checks medical technologies as well as foodstuffs and pharmaceuticals for approval in the USA on behalf of the US Department of Health. This involves defining stringent demands relating to the development and manufacture of such products and Olympus Surgical is required to undergo audits to prove its compliance with these. This also relates to the CIM DATABASE PLM platform used by the company: It must function correctly at the technical level and must be able to control and document the product development process employed at Olympus in conformity with regulations. CONTACT conducts the required software verifications and supports the medical technology manufacturer in the validation of its PLM environment.
To perform quality assurance in its software development operations, CONTACT uses state-of-the-art methods and IT tools – including its in-house solutions CIM DATABASE for documentation and Project Office for project management. These are interfaced with the software configuration management system Subversion. Development is organized on the basis of the Open Unified Process "OpenUP" and task control is handled via Project Office using checklists, milestones and activities. Document templates for new developments, further developments and corrected errors make it possible to maintain up-to-date documentation throughout the development phase. Requirements, change requests and hotline calls, as well as implementation, test and delivery versions are recorded in the central PLM database for each individual project. In this way, CONTACT can transparently meet its documentary and traceability obligations with regard to customers and supervisory bodies at all times.
The PLM supplier uses the Gherkin language for the methodical, automated testing of its software. On the basis of a current total of over 1,500 use cases, this language makes it possible to simulate typical user actions and indicates whether or not the software functions correctly. In 2013, CONTACT's customers will also be able to use this QA tool and the test case libraries to validate their PLM installations.
As the high-tech specialist in the Olympus Group, Olympus Surgical acts as the development and production center for endoscopy, bipolar high-frequency surgery, system integration in operating rooms and the reprocessing of medical instruments for the global market. This medical technology manufacturer is currently one of the leading suppliers in the field of minimally invasive surgery. Their main areas of business are urology, gynecology, surgery, ENT and arthroscopy. The group of companies, which is headquartered in Hamburg and employs a workforce of 1,100, develops and produces therapeutic and diagnostic system solutions for these application areas.
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