Medical Device companies have to manage complexity and regulation without placing excess overhead on their designers. Devices complexity has led to increased complaints, CAPAs, observations, and recalls. The root cause is frequently insufficient and cumbersome design control.
Digitalization helps them design with agility while maintaining control. It improves speed, accuracy, and productivity by automating submissions, DMRs, and DHFs from design data. The digital approach transitions device manufacturers away from document-centric and paper-based processes, or the electronic equivalent of processes that originated on paper that have been automated but never digitalized.
Digital design leverages complete digital models and creates a complete digital thread of information through design and the product lifecycle. It allows a cohesive approach where each step in design builds on the previous, and results in a digital model that engineers can use to validate and verify the behavior of the physical product in digital form using simulation.
Digital design control helps medical device companies get devices approved more quickly, keeps quality high, reduces risk, controls cost, and helps companies get innovative product to market quickly. The results are faster time to market, increased quality, and improved compliance.
This video series is sponsored by Siemens, a leader in digitalization for the manufacturing industries.
Click here for more information on intelligent design control in the medical device industry from our sponsor, Siemens, a leader in digitalization for the manufacturing industries.