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.

Acrylic beads for medical applications undergo rigorous conformance checks and extensive quality control measures, due to the nature of their use. Accredited documentation is critical for registering a medical device, but this is not a straightforward process. Determining the relevant information required by a certified body may include everything from product registration from all raw materials providers to quality assurance process information. Every region represents a unique challenge, especially in markets where these requirements are more stringent.

Makevale’s experience with medical device manufacturers means that our scientists are well versed in the complexities that come with regulations and certifications. This is the case to such an extent that the company’s manufacturing processes all conform with the most stringent requirements for medical device manufacturing.

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White Paper  Makevale assists with regulatory hurdles for large bone cement manufacturer Download