Regional regulatory expertise that expedites approval.
At Invibio we recognize the importance of working with you, our customers, to support regulatory submissions worldwide. Our global team of regulatory experts has a history in the orthopedic industry and understands the regulatory pathway. This allows us to provide valuable guidance and access to application-specific information regarding PEEK-based biomaterials and their predicate use in joint reconstruction and arthroscopy.
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 CFDA, 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.