CIMdata PLM Industry Summary Online Archive
5 April 2005
Implementation Investments
Transoma Medical Uses Agile PLM to Meet Regulatory Requirements as it Develops its First Medical Device
Agile Software Corporation announced that Transoma Medical, a pioneer in the use of wireless implantable sensors for monitoring vital signs in biomedical research animals, is using Agile 9 to help manage their business processes and meet compliance regulations as they develop their first medical device.
Founded in 1984, Transoma Medical created the market for wireless implantable sensors in biomedical research. A long time user of Agile 8, Transoma Medical recently made the transition to Agile 9 to assist in the develop their first medical device, an implantable diagnostic product for remote monitoring of pressure inside the heart that will aid physicians in the management of patients with heart failure. During the transition to Agile 9, Agile maintained the data integrity to ensure that critical information was not lost during the data migration process. Agile 9 provides Transoma Medical enhancements to the user interface, enables customized process workflows, and improves the company's verification and validation processes.
"The Agile 9 solution ensured that we met the stringent regulatory requirements as defined by the medical device industry," said Vic Fabano, vice president of manufacturing operations, Transoma Medical. "We received great technical support during our migration to Agile 9, and the flexible licensing allowed us to increase the number of internal users who needed immediate access to the software without incurring additional expenditures. We're looking forward to implementing the multitude of Agile 9's increased functionalities in the coming weeks."
Agile 9 provides a broad suite of business-ready, best-practice PLM solutions built on a unified enterprise PLM architecture. The suite features the new Agile Product Governance and Compliance solution for managing product compliance to industry standards and regulations, the expanded Agile Product Portfolio Management offering, and greatly enhanced versions of the Agile Product Collaboration, Agile Engineering Collaboration, Agile Product Cost Management, and Agile Product Service and Improvement solutions.
"Based on our collaborative relationships with our customers, we incorporated within Agile 9 the components that mattered most to their business-increased flexibility to address more unique business processes, a host of new applications and functionality, and broader user access," said Jay Fulcher, Agile president and COO. "As Transoma Medical prepares to take this next step into an exciting new market, we're pleased that the company's upgrade to Agile 9 is helping ensure regulatory compliance and reduce costs, while aiding in the innovation of medical devices that make a difference in people's lives."
Transoma Medical is the leading provider of wireless implantable sensors for biomedical research. Its DSI Division serves contract research organizations, pharmaceutical manufacturers and academic research institutions by providing an approach to monitoring vital signs of experimental animals that requires far fewer animals and is more humane and efficient than traditional approaches of gathering this data. Transoma Medical's Human Clinical Division is leveraging the Company's technology platform for remote wireless monitoring into products that will improve the lives of patients with chronic disease.
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