Arena Announces Availability of On-Demand Product Lifecycle Management for Medical Device Industry
Foster City, Calif., Aug 26 - Arena Solutions, Inc., the leading provider of on-demand Product Lifecycle Management (PLM), today announced availability of a comprehensive solution for medical device companies seeking to manage the risks and expense associated with FDA compliance while cutting the cost and time it takes to bring new products to market. Arena
Arena’s PLM solution for medical device companies is designed to support industry requirements for the rapid development and introduction of innovative new products while simultaneously complying with FDA requirements, such as Title 21 CFR Part 11, which defines accepted use of electronic records and signatures. Arena provides a comprehensive solution package, which includes implementation guidelines with best practices, validation planning guidelines, validation protocols and professional services.
“Using Arena’s Validation Kit saved us thousands of dollars and at least a month of work. We were able to map our quality operating procedures and user requirements to Arena’s validation protocol templates and run the entire validation in less than a week,” said David Sapuppo, vice president of manufacturing and quality assurance representative for Zassi Medical Evolutions.
Because Arena is the only company that provides an on-demand solution for the medical device industry, its customers realize the value of comprehensive PLM far more rapidly and at much lower risk and cost of ownership than with any other PLM vendor. Arena’s complete PLM solution manages the medical device product record throughout research and development, clinical trials, regulatory approval, and market entry, through end of life.
“Arena’s on-demand delivery model, rich PLM functionality and specialized solution for the medical device industry provide extraordinary benefits,” said Michael Topolovac, chief executive officer of Arena Solutions. “Customers achieve a much faster time to implementation and dramatically reduce the cost and risk of deploying PLM. Arena PLM allows our medical device customers to put more of their research and development budgets into actual product innovation by reducing their cost of compliance with rigorous and obligatory FDA regulations.”
“In order to remain competitive and profitable as a virtual manufacturer we have to minimize overhead while maintaining document controls without sacrificing compliance to any regulatory requirements,” said Sapuppo. “Arena PLM is an externally hosted server solution that really works far better than our older internal server-based application.”
“Arena’s on-demand PLM application has reduced downtime and helped cut Align’s design-to-delivery process from 22 days to five,” according to Meredith Yost, document services manager for Align Technology.