Siemens PLM Software is calling the Teamcenter for Medical Devices solution it developed with Tata Consultancy Services the first fully integrated product lifecycle management solution for the medical device industry.
The solution provides management for medical device lifecycles. All product activities, including medical device histories, compliance requirements and quality assurance standards from device concept to retirement, can be traced using Teamcenters integrated compliance management, traceability and reporting capabilities, according to an Oct. 23 statement from the partners announcing the products general availability.
Facilitating PLM (product lifecycle management) results in faster design cycles, accelerated regulatory approval and lower design, manufacturing, testing and tracing costs. Incorporating compliance management into the solution eliminates manual data entry and associated errors, and reduces compliance costs, the companies said.
In the healthcare and medical device industry, unifying product specification and compliance documentation to submit to the Food and Drug Administration can be a tedious process, said Daniel Flick, director of global alliances for Siemens PLM Software, in Plano, Texas. Flick said that approval submissions to the FDA are down, while the number of infractions is up, as a result of the inability to trace documents and the difficulty of compliance. "Its a dilemma for the industry in general," he said.
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Automatically linking compliance mandates with engineering and specification data helps ensure that medical device manufacturers address strict regulatory and quality guidelines from the start, and gives medical device OEMs a competitive edge, the companies said.
The softwares open architecture and the ability to track design and engineering specifications and compliance data from one supplier makes Teamcenter 2007 unique, Flick said. Teamcenter 2007 is available now, and can be used to address compliance and regulatory issues in industries such as aerospace, defense and manufacturing as well as healthcare, Flick said.
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