3DEXPERIENCE is a catalyst for innovation, enabling any enterprise stakeholder to participate in the innovation process, contributing to drive value for the end consumer.
Increasing regulatory scrutiny is putting Medical Device manufacturers under the gun on total quality and safety. With the number of FDA (Food & Drug Administration) warning letters issued on the rise, the time and budget Medical Devices manufacturers spend on regulatory activities is on the arise. In fact, one-third of Medical Device R&D job openings are in Quality and Regulatory, and one-quarter of the industry’s R&D spending goes to regulatory activities. The time and cost to obtain market authorization is increasing, while the number of regulatory submissions accepted in the first round are down.
Medical Device leaders need a single environment to manage critical aspects of their business and accelerate the innovation process. Successful companies will position themselves to jumpstart projects by leveraging structured business information based on customer feedback, supplier or internal best practices, while treating regulatory compliance as an asset in the development process, rather than an unwieldy requirement. Compliance and innovation must become complementary rather than conflicting processes.
Dassault Systèmes has a long history in the Medical Device industry helping leaders create and launch breakthrough innovations. From low-complex devices to high-complex devices – Class I, Class II and Class III – from small organizations to very large, global enterprises working with suppliers, our solutions allow device companies to accelerate the rate of innovation while maintaining total quality and reducing regulatory risk.