Regulatory Support
Working with you to help you through the journey to clearance and beyond
Your long-standing, trusted partner in high performance polymers
Zero material-related recalls
PEEK-OPTIMATM polymers have gained the trust of healthcare professionals, patients and OEMs with zero material related-recalls
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
Compliance with PEEK-OPTIMA™ polymer implantable devices - what does it mean for you?
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).
