Siemens Unveils First PLM Solution for Medical Devices

 
 
By Sharon Linsenbach  |  Posted 2007-10-23 Email Print this article Print
 
 
 
 
 
 
 

Teamcenter 2007 integrates compliance capabilities with design and engineering functions.

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. To read about how Siemens tailors unified communications for SMBs, click here. 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. Check out eWEEK.coms for the latest news, commentary and analysis on regulatory compliance.
 
 
 
 
Sharon Linsenbach Sharon Linsenbach is a staff writer for eWEEK and eWEEK Channel Insider. Prior to joining Ziff Davis, Sharon was Assistant Managing Editor for CRN, a weekly magazine for PC and technology resellers. Before joining CRN, Sharon was an Acquisitions Editor for The Coriolis Group and later, Editorial Director with Paraglyph Press, both in Scottsdale, AZ. She holds a BA in English from Drew University and lives in the Philadelphia suburbs with her significant other and two neurotic cats. When she's not reading or writing about technology, Sharon enjoys yoga, knitting, traveling and live music. Sharon can be reached at Sharon.Linsenbach@ziffdavisenterprise.com.
 
 
 
 
 
 
 

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