With the support of our partner supplier Quadrant EPP we understand the technical, compliance and regulatory aspects associated with the use of polymers in Medical and Life Science applications including materials for medical implants. Using this experience, we can support our customers with materials that are the correct technical choice supported by regulatory and compliance expertise.
Examples of the advantages we can bring to our customers are
- Confidence: Rely on a competent partner to choose the “right material” for sensitive Medical and Life Science applications.
- Compliance: Our partnership suppler Quadrant EPP’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 fulfil security and regulatory requirements of notified bodies. These grades have been developed and tested for biocompatibility according to ISO 10993 and USP requirements. Certification and documentation is provided and established. For implantable UHMW-PE development and manufacturing, Quadrant EPP is ISO13485 certified; these grades are intended for long-term implantation.
- Choice: Choose from a broad range of Engineering Plastics such as PEEK, PAI, PEI, PPSU, Acetal C 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.
- Surgical instruments and handles
- Endoscopy components
- Trays for implants and instruments, Target Devices
- Orthopedic / Joint Reconstruction: Implants and Trial implants, instrument components
- Dental Instruments
- Imaging Equipment
- Anaesthetic and Therapy Equipment