faster us market launch with medical devices
Getting medical devices approved in the US can be a huge market advantage—if you do it right. In Europe, a lot of manufacturers are dealing with long development times as they try to meet new regulatory requirements from the Medical Device Regulation (MDR). The US Food and Drug Administration (FDA), on the other hand, offers opportunities to reach your goal faster, including through more extensive options for the use of computer-aided engineering (CAE) and computational modeling and simulation (CMS) in the approval process. Digital models replace expensive prototypes, reduce physical testing and animal testing, and can significantly shorten the development time to actual market entry.
However, the successful use of these technologies requires technical expertise and valid documentation – challenges that involve considerable risks and which many companies cannot overcome on their own. This is where external support comes in. What is needed are partners who combine industry expertise with in-depth experience in the application of simulations, who can provide the necessary technical infrastructure and who also have up-to-date knowledge of regulatory requirements in the various global markets.
In our white paper, we show how you can use modern simulation technologies to obtain FDA approval not only faster but also more cost-effectively. Find out what requirements must be met, what role various norms and standards play, and how the EDAG Group can support you in building up expertise in digital tools and methods such as simulation, modeling, and digital twins.
Download the white paper "Efficient approval of medical devices using CAE" right here!
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