In order to succeed in an increasingly competitive and highly regulated market, medical device companies need to focus on business design processes and managing intellectual assets effectively across the medical-device value chain. The ENOVIA Life Sciences Accelerator for Engineering Design provides design control capabilities to manage all elements of the Device Master Record (DMR) with a single, integrated system. This includes product data such as mechanical and electrical bills of materials (BOMs), CAD models, configurations and related documentation such as drawings, specifications, procedures and quality standards. It also aggregates all information related to products and parts from other business processes and functions within a company’s product lifecycle management system.
“No other industry is as regulated as Life Sciences and regulatory compliance is often a critical success factor in launching new products. It’s therefore vital that we are able to stay compliant across a number of regulatory agencies, including the FDA,” said James Rolfe, IT program manager, MEDRAD. “ENOVIA’s solutions enable us to bring products to market quickly and more reliably by allowing us to focus on the creative aspects of the design, rather than the administrative details.”
Announced on May 29th, 2008, the Dassault Systèmes V6 platform provides an open, online collaborative environment, on a single IP management platform, for all product lifecycle activities. The V6 architecture also includes ready-to-use business processes, such as program, compliance and quality issues management, which support industry-specific PLM best practices and capabilities.
This approach ensures the Life Sciences Accelerator for Engineering Design addresses a customer’s need to manage and monitor entire product lifecycles in an ad hoc manner, while remaining on-time and on-budget. In addition V6’s IP Lifecycle Management of all product-related information, such as bills of material (BOMs) is a crucial element to ensuring the long-term compliance and success of many life science companies.
“Essentially, this solution is designed to be ‘a single source of the truth’ for medical device product structure and data,” said Mickey Garcia, director of life sciences industry strategy, ENOVIA, Dassault Systèmes. “As changes are made to the product design information, the Accelerator automatically updates this data throughout all the related systems.”
About Dassault Systèmes:
As a world leader in 3D and Product Lifecycle Management (PLM) solutions, Dassault Systèmes (Nasdaq: DASTY; Euronext Paris: #13065, DSY.PA) brings value to more than 100,000 customers in 80 countries. A pioneer in the 3D software market since 1981, Dassault Systèmes develops and markets PLM application software and services that support industrial processes and provide a 3D vision of the entire lifecycle of products from conception to maintenance to recycling. The Dassault Systèmes portfolio consists of CATIA for designing the virtual product - SolidWorks for 3D mechanical design - DELMIA for virtual production - SIMULIA for virtual testing - ENOVIA for global collaborative lifecycle management, and 3DVIA for online 3D lifelike experiences. Dassault Systèmes is listed on the Nasdaq (DASTY) and Eurolist (#13065, DSY.PA) stock exchanges. For more information, visit http://www.3ds.com.
CATIA, DELMIA, ENOVIA, SIMULIA, SolidWorks and 3D VIA are registered trademarks of Dassault Systèmes or its subsidiaries in the US and/or other countries.
Dassault Systèmes Press Contacts:
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Derek Lane (DS Americas)
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Mikiko Igarashi (DS AP)
Arnaud Malherbe (DS EMEA)
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