Thornton-Cleveleys, UK (PRWEB) March 14, 2013
Invibio Biomaterial Solutions' innovative PEEK-OPTIMA® family of biomaterials – including the world's first implantable grade polyetherketone (PEEK) polymer – have achieved considerable regional regulatory milestones, particularly significant in the current regulatory climate, it was announced today by Invibio director of Regulatory Affairs, Craig Valentine. As of February 2013, the number of implantable medical devices manufactured from PEEK-OPTIMA and cleared for market in the US reached 500, with more than 80 approved for market in China*.
“The regulatory environment globally is more challenging than ever. Support of data and knowledge through the process can help device companies overcome regulatory barriers. We are committed to continuing our investments in resources to support medical device companies’ regulatory submissions across global markets. Invibio maintains a Drug & Device Master file data at the US FDA and has specific test data required for both China and Japan available to customers on file. This data is utilized by the regulatory authorities and provides the verification of PEEK-OPTIMA’s biocompatibility and biostability, which is supported by a dedicated global regulatory team,” said Valentine.
Valentine noted “As medical device companies look for growth in BRIC countries, as evidenced by recent market acquisitions, knowledge and experience of the regulatory pathway is an advantage to speeding access to market”. The steady rise in the medical device industry's use of PEEK-OPTIMA in spine as well as other applications is mirrored elsewhere around the globe as well with PEEK-OPTIMA based implantable medical devices approved in all the BRIC emerging mar
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