MedicalExcellence in colors

The medical industry is an extremely demanding, highly regulated market requiring stable formulations, supply continuity and an in-depth knowledge of polymers and their properties to ensure reliable and consistent product quality. At Granula Group, we understand the importance of selecting the appropriate high-performance compound, in order to meet design and cost specifications. Granula will work directly with manufacturers to assess specific material needs and to formulate customized additive solutions to achieve specific performance properties. Customers can rely on our expertise to avoid interactions between pigments, polymers and additives to arrive at a safe, functional and commercially successful end product.

Hygiene protection

To rule out potential hygienic hazards, medical devices and components are subjected to various sterilization procedures, which ideally should not impact the product properties. However, not all materials are able to withstand the rigors of the various sterilization techniques used, resulting in shrinkage, melting and warpage. Granula can develop tailor-made formulations to ensure these components and devices continue to meet the specified criteria.

Traceable safety

The possibilities are endless: Granula produces a wide range of additives, including functional masterbatches with antimicrobial and aseptic properties, UV protection and, optionally, scratch resistance and resistance to disinfectants. If required, our colour masterbatches and compounds are developed for the medical market to meet the various requirements for medical devices. Our product range also includes effective products for achieving cycle times for injection moulding applications and laser marking additives for permanent marking. These products can also withstand sterilisation processes.

ISO 13485

To meet the requirements of the medical device industry, Granula implements the internationally recognised ISO 13485 (MedTech) quality system with objective proof of compliance.

All medical masterbatches and compounds are manufactured at Granula under IS0 13485:2003 certification. We guarantee full traceability of all batches, back to the raw materials used and the suppliers of these raw materials. All our masterbatches are also manufactured under strict controls with regard to traceability, consistency and change history.

MDR compliance in masterbatch production

The European Medical Device Regulation (MDR, EUR 2017/745) has been in force since May 2021 and replaces the previous Medical Device Directive (MDD). It sets out comprehensive requirements for the manufacture, approval and market surveillance of medical devices. Raw material suppliers such as masterbatch manufacturers are also affected if their products are intended for use in medical applications. Granula® masterbatch and colour masterbatch are manufactured in accordance with MDR for specific products with corresponding confirmations and material safety data sheets.

MedicalExcellence in colors

Hygiene protection

Traceable safety

ISO 13485

MDR compliance in masterbatch production

Learn how Granula can create customized solutions for your specific medical needs.