Introduction to this whitepaper

High performance polymers have transformed medicine over the last 100 years. Polymer beads are used in some of the most demanding applications, such as bone cements (for implant fixation) and maxillofacial fillers.

Due to the strict international standards, finding the right material can be difficult for medical device manufacturers. Regional approval is one of the biggest barriers preventing medical devices from launching.

At Makevale, we've plenty of international experience, in some of the strictest markets for international regulation. In this guide, we outline some key considerations for gaining approval in respect of your materials.