Regulatory Support
Working with you to help you through the journey to clearance and beyond
Changes in the regulatory landscape
Head of Regulatory Affairs and Product Stewardship, Caroline Prisk, explains how the regulatory landscape is changing for medical devices made with PEEK polymers, and presents the opportunities it can bring to the industry. Compliance and speed to market are important for our customers, and helping you to navigate new and complex regulatory pathways is a top priority.
Helping you on your journey to commercialization
European Union Medical Device Regulation (MDR)
Compliance with PEEK-OPTIMA™ polymer implantable devices - what does it mean for you?
Launching a PEEK-OPTIMATM HA Enhanced device, and already have a product in the market?
The FDA Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer’s own legally marketed predicate device (“existing device”) that is already authorized for commercial distribution through 510(k) clearance.
Expand your PEEK portfolio globally
Our team of global regulatory affairs experts can support you to navigate regulatory pathways, provide you with supporting documents & facilitate workshops between you and authorities including the FDA, European Conformity and China's National Medical Products Administration (NMPA).
