Dassault Systemes announced the launch of a new industry solution experience for medical device manufacturers called "Licensed to Cure." Based on the company's 3DEXPERIENCE platform, Dassault says the solution helps accelerate the delivery of innovative, safe, and fully compliant medical devices.
According to the company, the solution "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 Systemes. "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."
The solution 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. According to the company, it automates "bureaucratic" tasks and ensures procedural enforcement that leads to making products right the first time, speeding time to regulatory approval.
It provides structured process and documentation such as "living" DHF and DMR to enable full traceability and automated reporting and filing. It can also optimize medical device manufacturers' supply chains and extended ecosystems, to reduce compliance and quality risks while securing brand equity and image with consumers.
For more information, visit Dassault Systemes.
Sources: Press materials received from the company and additional information gleaned from the company's website.