Regulatory Support

Working with you to help you through the journey to clearance and beyond

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Overview

Your long-standing, trusted partner in high performance polymers

ZERO

fast fact

Zero material-related recalls

PEEK-OPTIMA^TM polymers have gained the trust of healthcare professionals, patients and OEMs with zero material related-recalls

20+

fast fact

Decades of proven clinical history

Over 20 years ago, the biocompatible PEEK-OPTIMA^TM Natural polymer became the material of choice in interbody fusion with a successful clinical track record

15M

fast fact

Millions of devices implanted worldwide

Today, approximately 15 million PEEK-OPTIMA^TM devices are implanted worldwide

leaders in innovation

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.

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pathway to launch

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?

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Launching a PEEK-OPTIMA^TM 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.

Ask us about the Special 510(k) Program

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).

Regulatory Support

Your long-standing, trusted partner in high performance polymers

Changes in the regulatory landscape

Helping you on your journey to commercialization

European Union Medical Device Regulation (MDR)

Launching a PEEK-OPTIMATM HA Enhanced device, and already have a product in the market?

Expand your PEEK portfolio globally

Launching a PEEK-OPTIMA^TM HA Enhanced device, and already have a product in the market?