Medical / Life Science Grades
Our Key Manufacturer Quadrant Engineering Plastic Products supplies semi-finished materials for the Life Science sector, for applications in the pharmaceutical, biotechnology, orthopaedics, analytical and dental industries. .
Quadrant’s “Life Science Grades” are approved for body and tissue contact up to 24 hrs (with the exception of 30 days for Ketron® CLASSIX™ LSG PEEK) and fulfill security and regulatory requirements of notified bodies. These grades have been developed and tested for biocompatibility according to ISO 10993 and USP requirements. They allow for expedited medical device clearance. In addition, Change Control Processes to comply with notifications and change requests are established for Quadrant’s “Life Science Grades”. Certification and documentation is provided and established. For implantable UHMW-PE development and manufacturing, Quadrant is ISO13485 certified; these grades are intended for long-term implantation.
Rely on a competent partner in design and feasibility process to choose the “right material” for sensitive Medical and Life Science applications. Quadrant has a long-term history of and experience in supplying Engineering Plastics Solutions for Life Science and Medical applications.
Choose from a broad range of Quadrant’s proven Engineering Plastics such as PEEK, PAI, PEI, PPSU, POM and implantable grade UHMW-PE having long-term and proven records in the Medical and Life Science Industry. All products are supplied with certification confirming USP Class VI and ISO 10993 compliance.