Dassault Systèmes Introduces “Licensed to Cure”, a New Industry Solution Experience for Fully Compliant Medical Devices

02/10/2012

“Licensed to Cure” Empowers Organizations to Master the Complex Relationships between Product Innovation, Quality Assurance and Regulatory Compliance

VELIZY-VILLACOUBLAY, France– October 2, 2012 - Dassault Systèmes (Euronext Paris: #13065, DSY.PA), the 3DEXPERIENCE Company, world leader in 3D design software, 3D Digital Mock Up and Product Lifecycle Management (PLM) solutions, today announced the launch of a new industry solution experience for medical device manufacturers called “Licensed to Cure.” Based on Dassault Systèmes’ 3DEXPERIENCE platform, it helps accelerate the delivery of innovative, safe, and fully compliant medical devices.

“Licensed to Cure” industry solution experience ensures a single source of information for innovation, as well as a fully-transparent and fully-documented change process allowing medical device manufacturers to optimize resource allocation, maximize IP reuse, and streamline the regulatory filing process. By creating an end-to-end, traceable, and compliant product development process that is directly linked to quality management, medical device manufacturers can expedite time to market and minimize regulatory overhead.

“Increasing regulatory scrutiny is putting pressure on medical device manufacturers to achieve total quality and safety,” said Monica Menghini, Executive Vice President, Industry and Marketing, Dassault Systèmes. “With the number of FDA warning letters issued on the rise, the time and budget that these manufacturers spend on regulatory activities is increasing. Our 3DEXPERIENCE platform, with dedicated industry solution experiences enables companies to manage their business objectives in a complex regulatory environment while meeting consumers’ expectations for safe products.”

Launched during the AdvaMed 2012 Conference, “Licensed to Cure” industry solution experience:
• Allows companies to eliminate scattered processes and data, and to “embed” regulations as an asset, optimizing quality and compliance and reducing cost and time to market.
• Ensures a single source of information that allows manufacturers to always get relevant, up-to-date information and establish true collaboration with the same, accurate set of product data.
• Automates “bureaucratic” tasks and ensures procedural enforcement that leads to making products right the first time, speeding time to regulatory approval.
• Provides structured process and documentation such as “living” DHF and DMR bring full traceability and automated reporting and filing.
• Helps medical device manufacturers accelerate and increase the innovation pipeline to sustain market expansion in new countries and with specialized products to meet patient needs without limits from risk mitigation and regulatory restrictions.
• Optimizes medical device manufacturers’ supply chain and extended ecosystem, to reduce compliance and quality risks while securing brand equity and image with consumers.
Dassault Systèmes at AdvaMed
“Licensed to Cure” will be showcased at AdvaMed 2012 Conference - booth #101. In addition, Dassault Systèmes is moderating a panel entitled, “Enabling Faster and Better Medical Device Development & Evaluation via Virtual Collaboration Simulation & Regulatory Submission.” Panelists from the FDA, Iyno Advisors and Bausch & Lomb will discuss how the FDA and the Center for Devices and Radiological Health (CDRH) are working collaboratively with federal government partners and external constituencies to advance device regulatory science and ensure the safety and performance of new products.

To learn more about “Licensed to Cure” and all of Dassault Systèmes’ Life Sciences industry solution experiences : http://www.3ds.com/life-sciences 

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Über Dassault Systèmes

Dassault Systèmes, die 3DEXPERIENCE Company, ermöglicht Unternehmen und Menschen durch virtuelle Welten nachhaltige Innovationen tatsächlich erlebbar zu machen. Seine weltweit führende 3D-Design-Software sowie Lösungen für digitale Prototypen in 3D und Product Lifecycle Management (PLM) erschließen vollkommen neue Wege, Produkte und Anlagen zu konzipieren, produzieren und zu warten. Die Dassault Systèmes 3DEXPERIENCE Plattform besteht aus dem folgenden Bausteinen:

•     Plattform für soziale Innovationen, basierend auf den Brands ENOVIA und 3DSWYM
•     Plattform für suchbasierte Anwendungen(SBA) mit den Brands EXALEAD und NETVIBES
•     Plattform für die Aufbereitung und Simulation von Produkt- und Prozesswissen, unterstützt durch die Brands 3DVIA, DELMIA und SIMULIA
•     Plattform für 3D–basiertes Design und Modellierung mithilfe der Brands CATIA und SOLIDWORKS Real Time Experience - die offene und flexible
•     Plattform für die funktions- und unternehmensübergreifende Anwendungs- und Prozessintegration.

Der Konzern betreut über 150.000 Kunden jeder Größe und in allen Branchen in mehr als 80 Ländern.

CATIA, SOLIDWORKS, SIMULIA, DELMIA, ENOVIA, GEOVIA, EXALEAD, NETVIBES, 3DSWYM und 3D VIA sind eingetragene Warenzeichen von Dassault Systèmes oder seinen Tochterunternehmen in den USA und/oder anderen Ländern.