PLM solution for the medical device market enables regulatory compliance
Westford, MA — November 17, 2003 — MatrixOne Inc., a provider of collaborative product lifecycle management (PLM) solutions, today announced the availability of the MatrixOne Accelerator for Food and Drug Administration (FDA) Compliance, which it said is designed specifically to help medical device manufacturers achieve FDA compliance throughout their product lifecycle processes, while reducing product development costs and accelerating new products to market.
MatrixOne said its Accelerator for FDA Compliance offers a solution to facilitate and automate business processes and is designed to assist with regulatory compliance on a global basis. Companies in the medical device industry must ensure FDA compliance throughout the entire design and manufacturing process. Specifically, as regulated companies, medical device manufacturers must ensure compliance with evolving FDA Regulations such as those outlined in Title 21 of the Code of Federal Regulations (CFR), especially 21 CFR Part 11 and 21 CFR Part 820.
Pete Schaubach, chief information officer for ev3, said, "The Accelerator for FDA Compliance has been designed specifically to solve the problems we are facing as a medical device manufacturer. It includes the specific applications, nomenclature and business processes we need to enable us to deliver products to market that are compliant with Federal regulations. This is important for us as a company because it ensures that the innovation we are creating can be brought to market and utilized as quickly as possible."
The Accelerator for FDA Compliance also allows medical device manufacturers to create secure, collaborative project spaces for virtual teams, including global development teams and outsourced partners. It allows them to electronically manage all product information, including the Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR), as well as all non-product related documents such as global product documentation, procedures, trademarks, contracts and patents throughout the product lifecycle while maintaining full audit trails.
By having a single view of the product lifecycle process, MatrixOne said medical device manufacturers will be able to keep their engineering, manufacturing, quality and materials departments synchronized on new or changing product information, resulting in improved consistency, quality and volume, and faster compliance and submissions with the FDA requirements.