MatrixOne
CompanyCustomer_successSolutionsServicesPartnersInternational

Company
home > company > press room > press releases
Search
Overview

Investor Relations

Press Room

Press Releases

Media Coverage

Information Kit

Industry Analysts
Events

Careers

Offices


Home
Contact Us
Site Index

PartnerLink

Press Room
Press Releases

Press Contacts: Charlie Guyer
MatrixOne, Inc.
T. 978 589 4052
Charlie.Guyer@matrixone.com
  Ed Harrison
fama PR
T. 617 758 4144
Ed@FamaPR.com
 
Download .pdf

MatrixOne Introduces its Accelerator for FDA Compliance; A PLM Solution Designed Specifically for the Medical Device Market

Solution Enables Medical Device Companies to Ensure Regulatory Compliance while Accelerating New Product Introductions

Westford, Mass. - November 17, 2003 - MatrixOne, Inc. (NASDAQ: MONE), a leading provider of collaborative product lifecycle management (PLM) solutions for the value chainTM, today announced the availability of the MatrixOne Accelerator for FDA Compliance, a single, PLM solution designed specifically for medical device manufacturers which helps them to achieve FDA compliance throughout their product lifecycle processes, while drastically reducing product development costs and accelerating new products to market. The MatrixOne Accelerator for FDA Compliance has been developed based on MatrixOne's rich domain expertise working with some of the world's most innovative companies in the medical device industry (also see today's announcement "ev3 Selects MatrixOne Product Lifecycle Management Solutions to Accelerate New Product Introduction For Medical Devices") enabling companies of all sizes to rapidly implement a state-of-the-art PLM environment that closely meets the needs of their business.

MatrixOne's Accelerator for FDA Compliance provides medical device manufacturers with 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 is a very attractive offering as it 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 that we need to enable us to quickly 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 MatrixOne Accelerator for FDA Compliance is an offering which allows medical device manufacturers to easily and effectively 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, 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.

The MatrixOne Accelerator for FDA Compliance allows medical device manufacturers to rapidly and efficiently deliver compliant products to market by:

  • Easily and effectively creating secure collaborative "Project Spaces" for virtual teams
  • Driving compliance with FDA 21 CFR Part 11; electronic records and signatures and with FDA 21 CFR Part 820; quality system regulations
  • Electronically managing all product information throughout the product lifecycle, including the Design History File, the Device Master Record, and the Device History Record
  • Easily managing the Phase/Gate design control processes through configurable, new product introduction process templates;
  • Effectively managing all product and non-product related documents such as internal procedures and specifications;
  • Dynamically linking Corrective Action / Preventive Action processes directly to affected product and/or non-product information.

Availability
The MatrixOne Accelerator for FDA Compliance is currently available through MatrixOne or one of its authorized resellers or distributors.

About MatrixOne
MatrixOne, Inc. (NASDAQ: MONE) is a recognized leader in delivering collaborative Product Lifecycle Management (PLM) solutions. We provide flexible solutions that unleash the creative power of global value chains to inspire innovations and speed them to market. MatrixOne's customers include global leaders in the aerospace and defense, automotive, consumer products, high technology, life sciences, machinery, and the process industries, including Agilent Technologies, General Electric, Honda, Johnson Controls, Philips, Procter & Gamble, Siemens, and Toshiba. MatrixOne (http://www.matrixone.com/) is headquartered in Westford, Massachusetts with locations throughout North America, Europe, and Asia/Pacific.

###

MatrixOne and the MatrixOne logo are registered trademarks and Collaborative Product Lifecycle Management Solutions for the Value Chain and MatrixOne Engineering Central are trademarks of MatrixOne, Inc. All other trademarks and service marks are the property of their respective owners.

Forward-looking statements in this release are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. Such statements may relate, among other things, to our plans, objectives and expected financial and operating results. The risks and uncertainties that may affect forward-looking statements include, among others: poor product sales, long sales cycles, difficulty developing new products, difficulty in relationships with vendors and partners, higher risk in international operations, difficulty assimilating future acquisitions, difficulty managing rapid growth, and increased competition. For more about the risks and uncertainties of our business, see our periodic and other S.E.C. filings.

up