Regulatory guidance that helps you enter more markets, faster.
At Invibio, we recognize the importance of working with you, our customers to support regulatory submissions worldwide. We have a global team of experts familiar with regulatory requirements for trauma devices and PEEK-based implants. Our regulatory team can provide guidance about the most relevant testing methods and predicate devices to include in regulatory submissions, which can dramatically reduce review times and accelerate device launch.
Invibio has unparalleled experience in bringing new biomaterial platforms to market with a level of support that allows medical device companies to navigate the regulatory pathway. The knowledge that allows our customers to link the performance of their end products to the data in our master files has allowed us to introduce a range of platforms over the last 10 years.
Invibio is actively engaged with global regulatory authorities including the China’s SFDA, PMDA, Japan and ANVISA, Brazil, to better understand regulatory requirements so we can help expedite device approvals. All regulatory submissions for devices using Invibio biomaterials include comprehensive data, spine testing support and are backed by regionally aligned Master Files and over a decade of proven clinical history.
The foundation is our comprehensive master files and global regulatory support that allows our customers to bring their devices to market faster, and more efficiently. In addition to the extensive material testing, application specific test data that proves our product platforms are suitable for use is instrumental in overcoming regulatory hurdles and in facilitating adoption.