AgileMD supports product lifecycle management, regulatory compliance demands at global medical device company
San Jose, CA — August 3, 2005 — Haemonetics, a global company engaged in the design, manufacture and worldwide marketing of automated blood processing systems, has implemented AgileMD, the Agile product lifecycle management (PLM) solution tailored for the medical device industry, to reduce its product development cycle time, enable collaboration and optimize its compliance assurance efforts.
The adoption of AgileMD is also expected to improve management of the product development pipeline and enable increased leverage of intellectual property from new technologies, according to Haemonetics.
"Haemonetics is strategically focused on profitable growth and operational excellence, and we wanted to work with a PLM solution provider that will enable us to meet our goals," said Robert Ebbeling, Haemonetics' vice president of operations. "We selected Agile because it offers a comprehensive PLM solution built on industry best practices. With AgileMD, we have the ability to manage the product record of the various medical devices in our portfolio throughout their lifecycles-from research and development through regulatory approval, new product introduction and end-of-life."
Dottie Barr, Haemonetics' director of business process development, said, "We considered several PLM solutions and selected Agile because of the breadth of the solution and Agile's proven experience with numerous other medical device customers. Because AgileMD is designed specifically for our industry, no customization was needed, and with Agile's proven track record and domain expertise, we experienced a very smooth deployment and validation."
According to Bryan Stolle, Agile CEO, medical device manufacturers have special profitability constraints that result from the unique demands of regulatory compliance, in the United States with the Food & Drug Administration, and with numerous other local, regional and international regulatory agencies. "Agile PLM solutions have been built to simplify regulatory compliance, optimize processes throughout the product lifecycle, and enable a closed-loop complaint handling CAPA system-functions that align well with Haemonetics' priorities," he explained.