Mitsubishi Chemical Advanced Materials has a long-term history in development, manufacturing and supply of Engineering Plastics used in Medical and Life Science applications. Cooperating closely with medical devices manufacturers, Mitsubishi Chemical Advanced Materials understands technical, compliance and regulatory aspects associated with the use of polymers in Medical and Life Science applications, including materials for longterm medical implants. Therefore, Mitsubishi Chemical Advanced Materials can provide you with the right technical choice supported by regulatory and compliance expertise.
Compliance: Mitsubishi Chemical Advanced Materials’ “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 with. 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 Mitsubishi Chemical Advanced Materials’ “Life Science Grades”. Certification and documentation is provided and established.
For implantable PEEK and UHMW-PE development and manufacturing, Mitsubishi Chemical Advanced Materials is ISO13485 certified; these grades are intended for long-term implantation.
Confidence: Rely on a competent partner in design and feasibility process to choose the “right material” for sensitive Medical and Life Science applications. Mitsubishi Chemical Advanced Materials has a long-term history of and experience in supplying Engineering Plastics Solutions for Life Science and Medical applications.
Choice: Choose from a broad range of Mitsubishi Chemical Advanced Materials’ proven Engineering Plastics such as PEEK, PAI, PEI, PPSU 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.
Capabilities: Mitsubishi Chemical Advanced Materials excels in the development of Engineering Plastics being converted to stock shapes and processed by injection moulding to meet the needs of the Medical Industry.
Mitsubishi Chemical Advanced Materials offers Life Science Grades which have been specifically developed for applications in the medical, pharmaceutical and biotechnology industries. The Mitsubishi Chemical Advanced Materials Life Science Grades portfolio includes plastics which comply with FDA, ISO 10993 and USP guidelines for biocompatibility testing of materials, saving testing costs and time while providing full traceability from raw material to stock shape.
Surgical instruments and handles
Endoscopy components
Trauma: Trays for implants and instruments, Target Devices
Orthopedic / Joint Reconstruction: Implants and Trial implants, instrument components
Analytical and Diagnostic Equipment
Dental Instruments
Imaging Equipment
Anaesthetic and Therapy Equipment
Biotechnology