Empowering Organizations to Master the Complex Relationships between Product Innovation, Quality Assurance, and Regulatory Compliance
Dassault Systèmes officials announce 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.